30 Equipment Validation Jobs

Dear All, We are looking for as Junior Engineer - Tool & Process development for GTTC, NTTF & CIPET holders. Job Description. New child parts development (tool and process) to meet master schedule a. Tool spec review, Tool design review b. Inspection report review c. Tool Correction plan review d. Schedule review e. Handover tool and process f. Co-ordinate with CFT to get and share information related to NPD g. Develop facilities that is unique for the part ECI implementation and monitoring Adherence to IATF requirement Master list control QCPC,PCA,FMEA,SMH, gauges, fixtures, trim tools, dies, moulds, part weight, shot weight, RM details. Meet the IOC requirements given by PC Follow Safety rules Continuously improve the process by nurturing the spirit of originality, enthusiasm and innovative challenges Work in harmony within department, with other departments and vendors to solve the problems. Implement gorika. Actively participate in suggestion scheme. Interested candidates can send resume at manohara.is@trmn.biz

Role & responsibilities Validation & Qualification of Equipment Experience in Autoclave, Terminal, Sterilizer, Mixing Vessel, Tunnel Qualification, washing machine and filling machine. HVAC Qualifications Validation and qualification protocol and report. To ensure material issuance for validations activities & keep Section Manager updated. To ensure implementation of validation, qualification activities & inform to Section Manager for any deviation from written procedure. Equipment Qualification Steam Heat Sterilizer, Terminal sterilizer, Preferred candidate profile:- Result orientated Communication skills Presentation skills Analytical skills Lateral coordination * Candidate can share their resume at anee.silas@otsukapharma.in

Job Role: CQV Engineer Experience: 2-4 years Location: Bengaluru Key Responsibilities: Authoring of commissioning protocols (e.g., Installation Checks, Functional Testing) for equipment and Utilities such as Reactors, centrifuges, dryers, HPLC etc. Participate and coordination with engineering & OEMS for FAT/SAT. Authoring of DQ, System Impact Assessment and Risk Assessment documents in coordination with OEM. Author, review, and execute qualification protocols: Installation Qualification, Operational Qualification, and Performance Qualification for process equipment. Perform Qualification as per the regulatory requirements (e.g., FDA, WHO) Should have sound knowledge in good documentation Practices and QMS process throughout the CQV lifecycle. Coordination with engineering, manufacturing, QA/QC, and IT teams to coordinate CQV activities and ensure seamless project execution. Provide technical input during project planning and scheduling of CQV activities. Track and report progress of CQV milestones, and support. Perform validation activities for the processes, facilities, utilities, manufacturing, and laboratory equipment in compliance with FDA regulations, Quality Management systems, Good Manufacturing Practices and 21 CFR Part 11 (Electronic Records and Signatures) Coordinate and interface with operations and quality assurance department, to develop supporting documentation, execution plans, risk assessment, user requirements, design qualification and life cycle documents for any improvements in the production methods and ensure compliance with cGMP regulations. Initiate and manage validation deviations in the testing of development process and equipment functioning. Analyze the investigations to identify the root cause of the deviations to define a corrective action. Ensure efficient operation of the pharmaceutical equipment to corroborate the drug quality meets clients standards, GMP and FDA regulations. Perform design review to ensure the equipment is installed and operates according to the user requirement specification.

Role & responsibilities MAJOR ACCOUNTABILITY (Mention core tasks assigned to associate etc.) 1. Preparation of Qualification documents for Pharmaceutical HVAC system. - URS, DQ, IQ, OQ, PQ 2. Execution of HVAC modification projects 3. Review of HVAC assessment reports for modification scope of HVAC systems 4. Review of BOQ for HVAC modification 5. Preparation of URS for Air Handling Systems 6. Preparation of QRA & CR for HVAC modification projects 7. Review of HVAC layouts i.e. System zoning, Pressure Zoning, Area Classification drawings 8. Review of Heat Load calculations 9. Integration of new AHUs with BMS system & BMS system qualification 10. Creation of Maintenance plan, Calibration plan for the HVAC systems 11. GMP & abiding and ensuring compliance to the Health, Safety & Environment policy. 12. Completion of all trainings assigned to role 13. Ensure integrity of data at workplace. 14. Ensure Good Documentation practices at workplace 15. Involvement in Detail Designing, Concept phase in Major/Minor Projects, Supervising and instructing third party contractor work 16. Weekly meeting with cross functional team to meet project timeline. 17. Daily startup meeting with team for complete project within timeline and to identify points which may impact on completion of project. 18. Vendor alignment to complete project timely and Vendor follow -up to timely resolve project problems 19. Handover area of equipment within define timeline to avoid process impact and Coordinate with cross functional team to complete project within timeline 20. Preparation of qualification document timely and Timely completion of project compliance action 21. Complete project within timeline with 21 CFR part 11 compliance and as per qualification sop. 22. Qualification documentation should prepare and execute with 100% accuracy without GXP error 23. All QMS actions should be completed within the assigned date. 24. Continuous improvement related to engineering to be initiate and complete at least 2 per year which will help to save R&M and time. 25. Installation and commissioning of FDF equipment as per GMP and Carrying out qualification activity as per SOP. Company : Sandoz Healthcare Location : Mumbai ( Kalwe ) Contract role and will be renewed yearly based share resumes to nedunuri.saikumar@manpower.co.in

Hi, We are hiring for ITES Company for Validation Associate Role. Job description ***Minimum 3 years as Validation Associate is required.*** 1. Data validation test script creation: Create necessary validation scenarios needed to ensure checks are functioning as required and document scenarios in the Data Validation Specification(DVS). Document expected results for each testing scenario. Feedback to the clinical Data Scientist (CDS) any ambiguities in logic that require clarification for testing scenario creation. 2. Data validation test script execution: Entry of test data as specified in each testing scenario Compare the result obtained through entry of the test data to the expected result. Re-execute all checks that do not pass to ensure they are actual failure. Document validation failures. For validation failures due to incorrect testing scenarios, update DVS and re-execute testing scenario. Re-execute and document within the DVS validation results for checks that required programming updates. 3. Validation of the SI data set creation process: Enter data into all study visits and forms. Extract data from InForm into SI datasets Generate list of data within InForm Generate list of data contained within SI datasets Compare InForm listing to the SI dataset listing. Document unexpected inconsistencies between listing. Review time slicing specification against the SI data sets to ensure time slicing variables are being accurately populated. Document incorrect/unexpected time slicing variable assignments. Compare the pre-defined variable values as specified in the DVS against the SI data sets. Document inconsistencies To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 171 b) To Apply for above Job Role ( Pune ) Type : Job Code # 172 c) To Apply for above Job Role ( Indore ) Type : Job Code # 174

Dear Candidates, Greetings from KEYBIZ DASHBOARDS, We are looking for Quality Assurance Executive & Sr.Executive injectables&OSD for one of our reputed pharmaceutical client, based at Hyderabad & Vizag location. Please find below openings list. 1.IPQA 2.QMS 3.AQA 4.Validation 5.Equipment Qualification 6.CSV 7.Market Complaints. The above positions we are looking for Hyderabad & Vizag locations, interested please share us updated cv to prasanthi@mydashboards.in or feel free to call on 6305391924 Thanks and Regards Prasanthi - Dashboards Team HR

Strategic: Representative for QMS activities in Drug product/ Drug substance area. Timely initiation and closure of QMS elements. Documentation related to Drug product/ Drug substance area. Training need identification for all the employees Assist the validations and routine validations of equipment and facility. Identify and implement the manufacturing and warehouse procedures with compliance to current GMP requirements. Coordination during customer and vendor audits. Coordinating with engineering and validation department for calibration and preventive maintenance. Coordination and implementation of software based QMS solutions like Track-wise, LMS, SAP etc. Operational: Initiation of change controls, deviations, Investigation and CAPAs and closure of the same. Tracking of QMS activities and coordinating with cross functional departments to complete the QMS activities like investigation for OOS, complaints, deviations. Identification, preparation and implementation of SOP’s. This position will prepare SOPs related to the machines which are undergoing commissioning and procedures which are proposed to implement in Drug product area. Preparation and review of URS, CLIA, SLIA, QRM, IQ and OQ documents. Involvement in the qualification activities of equipment and area in drug product area People: Champion the OneSource Core Values and lead by example by acting a member of a team to achieve organizational and common objectives. Identify business successors and coach, mentor, nurture and develop people towards leading the business as non-fungible assets in the organization with a succession and continuity plan. Preparation and execution of training modules on SOP’s in the department. Preparation and execution of QMS documents in the department. Preparation and execution of training modules on QMS and safety SOP’s in the department. Preparation and execution of training on soft skills to develop the team. Finance: Ensure activities, services and tasks engaged / managed meets or improves on budget, cost, volume and efficiency targets (KPIs) in line with business objectives. Ensure the availability / adequacy of resources to implement and maintain the pharmaceutical quality system and continually improve its effectiveness by applying resources to specific product, process or site.

Hi, We are hiring for ITES Company for Validation Associate Role. Job description ***Minimum 3 years as Validation Associate is required.*** 1. Data validation test script creation: Create necessary validation scenarios needed to ensure checks are functioning as required and document scenarios in the Data Validation Specification(DVS). Document expected results for each testing scenario. Feedback to the clinical Data Scientist (CDS) any ambiguities in logic that require clarification for testing scenario creation. 2. Data validation test script execution: Entry of test data as specified in each testing scenario Compare the result obtained through entry of the test data to the expected result. Re-execute all checks that do not pass to ensure they are actual failure. Document validation failures. For validation failures due to incorrect testing scenarios, update DVS and re-execute testing scenario. Re-execute and document within the DVS validation results for checks that required programming updates. 3. Validation of the SI data set creation process: Enter data into all study visits and forms. Extract data from InForm into SI datasets Generate list of data within InForm Generate list of data contained within SI datasets Compare InForm listing to the SI dataset listing. Document unexpected inconsistencies between listing. Review time slicing specification against the SI data sets to ensure time slicing variables are being accurately populated. Document incorrect/unexpected time slicing variable assignments. Compare the pre-defined variable values as specified in the DVS against the SI data sets. Document inconsistencies To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Bangalore Search : Validation Associate Bangalore (Job Code # 173) b) For Position in Ahmedabad Search : Validation Associate Ahmedabad (Job Code # 175)

Roles and Responsibilities Responsible for overall Quality System Review & Improvements Handling and control of Non-conforming products. Responsible for review & approval of key Quality System Procedures, Standard Operating Procedures & other Master Documents. GAP Analysis of the process and products. Identifying the scope of improvement based on trend analysis. Putting forward the suggestions for improvements to the Management. Participation in audits, compliance and Tracking of Audit Compliances/Status. Review & closeout of Change Controls, Deviation Complaints & CAPA. Participating in Impact assessment, investigation & approval of deviations. Review & Approval of change controls, Deviations, OOS, CAPA, Market Complaints, etc. Ensuring implementation of software based QMS in the Organization. Ensure Compliance of Software based QMS Systems. Responsible for clearance of rejected Raw & Packing Materials. Desired Candidate Profile Candidate should have good communication skills and Pharmaceutical OSD Experience required

Designation Senior Associate CQV (Quality Assurance) Department Quality Assurance Experience 5+Years Job Location Bangalore 4+ years of experience in FDA-regulated industry Knowledge of pharmaceutical laboratory and process systems; Experience with Biologics equipment preferred Job Responsibilities: Take charge as Single Point of Contact for site validation/qualification (Equipment & Facilities) requirements. Responsible for scheduling, planning and ensuring execution of qualification/requalification (equipment, facility HVAC, Water system, Gases qualification) related to facility. Prepare and review of qualification / requalification protocols and reports. Perform thermal mapping activities for equipment available at site using Kaye Advanced Validator System. Draft and review of SOPs related to validation, Commissioning & Qualification. To manage change control, deviations, CAPAs, risk assessments related to Facilities & Equipment. To provide initial and regular training to team and other department personnel SOPs & protocols related to Validation, qualification/ requalification. Handling and maintenance of validation accessories & managing inventory. Identify and qualify service provider for validation services providers. Participate in External Service Provider (Engineering services) audits. Preparation of project & validation plan for facility expansion, capacity enhancement project. Take lead as Validation In-charge for new equipment & facility commissioning.

Hi, We are hiring for ITES Company for Validation Associate Role. Job description ***Minimum 3 years as Validation Associate is required.*** 1. Data validation test script creation: Create necessary validation scenarios needed to ensure checks are functioning as required and document scenarios in the Data Validation Specification(DVS). Document expected results for each testing scenario. Feedback to the clinical Data Scientist (CDS) any ambiguities in logic that require clarification for testing scenario creation. 2. Data validation test script execution: Entry of test data as specified in each testing scenario Compare the result obtained through entry of the test data to the expected result. Re-execute all checks that do not pass to ensure they are actual failure. Document validation failures. For validation failures due to incorrect testing scenarios, update DVS and re-execute testing scenario. Re-execute and document within the DVS validation results for checks that required programming updates. 3. Validation of the SI data set creation process: Enter data into all study visits and forms. Extract data from InForm into SI datasets Generate list of data within InForm Generate list of data contained within SI datasets Compare InForm listing to the SI dataset listing. Document unexpected inconsistencies between listing. Review time slicing specification against the SI data sets to ensure time slicing variables are being accurately populated. Document incorrect/unexpected time slicing variable assignments. Compare the pre-defined variable values as specified in the DVS against the SI data sets. Document inconsistencies To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Bangalore Search : Validation Associate Bangalore (Job Code # 173) b) For Position in Ahmedabad Search : Validation Associate Ahmedabad (Job Code # 175)

Hi, We are hiring for ITES Company for Validation Associate Role. Job description ***Minimum 3 years as Validation Associate is required.*** 1. Data validation test script creation: Create necessary validation scenarios needed to ensure checks are functioning as required and document scenarios in the Data Validation Specification(DVS). Document expected results for each testing scenario. Feedback to the clinical Data Scientist (CDS) any ambiguities in logic that require clarification for testing scenario creation. 2. Data validation test script execution: Entry of test data as specified in each testing scenario Compare the result obtained through entry of the test data to the expected result. Re-execute all checks that do not pass to ensure they are actual failure. Document validation failures. For validation failures due to incorrect testing scenarios, update DVS and re-execute testing scenario. Re-execute and document within the DVS validation results for checks that required programming updates. 3. Validation of the SI data set creation process: Enter data into all study visits and forms. Extract data from InForm into SI datasets Generate list of data within InForm Generate list of data contained within SI datasets Compare InForm listing to the SI dataset listing. Document unexpected inconsistencies between listing. Review time slicing specification against the SI data sets to ensure time slicing variables are being accurately populated. Document incorrect/unexpected time slicing variable assignments. Compare the pre-defined variable values as specified in the DVS against the SI data sets. Document inconsistencies To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Validation Associate Mumbai (Job Code # 171) b) For Position in Pune Search : Validation Associate Pune (Job Code # 172) C) For Position in Indore Search : Validation Associate Indore (Job Code # 174)

Academic: 1. Should have minimum qualification of M.Sc preferably in chemistry. 2. Minimum 10+ years experience 3. Academic career should be good (preferably first class and above) 4. Candidate will be preferred having good communication skill and writing Job Profile: Equipment Qualification protocol / report review DQ, IQ, OQ, PQ, FAT & SAT Should have knowledge of API process equipment like reactor, centrifuge etc. Equipment URS review, Layout, P & ID review Handling of QMS documents Like Change control, Deviations, Incidences, Performing the Investigation using different investigation tools. Performing the Risk Assessment like nitrosamine Risk Assessment, Quality risk Assessment. HVAC Qualification, PP area Qualification. Handling of temperature mapping activities. Facility Qualification

Handling of Equipment Qualification, Area Validation, Process validation, cleaning validation, Risk assessment, Change control, Deviation, HVAC validation please share your profile & contact: Call: 8160615349/7878051751

Designation: Quality Assurance Chemist Location :Medchal, Hyderabad Qualification: B.sc/B.pharma Experience: Min.3 relevant exp as Qa chemist Package: 4-5LPA Shifts: General shifts If interested Contact: 8247381453 Share Cv laxmi@hireiton.com Required Candidate profile • Qualification of utilities like Purified Water systems • Reviewing BMR/BPR & issuing analytical worksheets, logbooks • Must have worked in a pharmaceutical company in the past

Hi, We are hiring for Leading ITES Company for Validation Associate Profile. Job Description Minimum 3 years as a Validation Associate is required. 1. Data validation test script creation: Create necessary validation scenarios needed to ensure checks are functioning as required and document scenarios in the Data Validation Specification (DVS). Document expected results for each testing scenario. Feedback to the clinical Data Scientist (CDS) any ambiguities in logic that require clarification for testing scenario creation 2. Data validation test script execution: Entry of test data as specified in each testing scenario Compare the result obtained through the entry of the test data to the expected result. Re-execute all checks that do not pass to ensure they are actual failures. Document validation failures. For validation failures due to incorrect testing scenarios, update DVS and re-execute testing scenarios. Re-execute and document within the DVS validation results for checks that required programming updates. 3. Validation of the SI data set creation process: Enter data into all study visits and forms. Extract data from InForm into SI datasets Generate list of data within InForm Generate list of data contained within SI datasets Compare the InForm listing to the SI dataset listing. Document unexpected inconsistencies between listing. Review time slicing specification against the SI data sets to ensure time slicing variables are being accurately populated. Document incorrect/unexpected time slice variable assignments. Compare the pre-defined variable values as specified in the DVS against the SI data sets Document inconsistencies Key Skills: a) Min 2 years of experience in eDC or non eDC b) Edit checks validation & script creation in any eDC systems like InForm, Veeva, Rave is required c) Any Graduate WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Bangalore Search : Job Code # 173 b) For Position in Ahmedabad Search : Job Code # 175

Position: Engineer Utilities Solvents Contract: On Permanent Role. Required Skill Set: Excellent verbal and written communication skills with success in building trustful relationships and influencing others in cross functional areas including customer management Experience in Pharma, Biotech industry is a must. Coordination with other disciplines conducting design review for engineering activities. Have experience in the perform the Gemba / quality checks for the required discipline. Estimation of Generation Capacities for Utility (Clean, Black, CIP, Waste Exhaust), Gases and solvents Prepare URS for Utility (Clean, Black, CIP, Waste Exhaust), Gases and solvents generation skids/equipment Distribution package Knowledge in Defining concept, designing, sizing and testing of clean black utility systems and process gases Solvents and distributions systems on both existing and new facilities. Experience with regulatory requirements, authority applications, GMP impact and calculation of energy consumption. optimization of design solutions to meet specific project technical commercial requirements. Prepare, Evaluate Finalize the tender for the utility Solvents packages. Have experience in qualification of the vendor and equipment (validation life cycle) Have experience in Planning Estimation of the project deliverables in the different phase of project. We re hiring Engineer Utilities Solvents for one of our Leading MNC to join their growing team. This position is based out in Bangalore. BE / B. Tech or M.Sc. / ME / M. Tech in Mechanical, Chemical or equivalent, with relevant experience 6 12 Years Experience require. Must have experience in CD, BD, DD Construction phases of project execution. Must have good knowledge of the current relevant Engineering Pharma legislation / regulations / guidelines / standards. Knowledge/ work experience in MS VISIO, AUTO CAD, NAVISWORK are preferred.

Responsibilities: Performing requirements analysis to develop overall testing strategy & individual test cases & protocols. Identify testing requirements & dependencies Work with relevant experts for generating testing Jigs and dependencies Performing unit testing, integration testing, and pilot unit verification and validation for all Electronic/Hardware/Embedded/Mechanical/Optical subsystems. Handle all V&V documentation including creating and maintain verification test plans & generating final reports. Work with design team to debug issues and perform root cause analysis. Coordinate with regulatory teams for identifying & performing 3rd party tests. Perform Component level validation and System level validation. Coordinate with clinical/applications specialists to complete clinical validation/evaluation/investigation as required. Preferred Skills: Strong analytical & abstract thinking, problem solving, creativity. Excellent oral, written communication skills. Prior experience participating in various activities associated with verification & validation of medical devices. Usage of test management tools including JIRA and others. Knowledge of Process Validation, Tools/Jigs/Fixtures Validation and Equipment Validation. Expertise in process & test automation and control. Comfortable with Arduino, python, Node js, C++. Comfortable interpreting PCB schematics & gerbers, drawings, & PRD. Fluency with Excel, Word, Jira, Notion.

NNE is looking for a people with a curious consulting mindset and solid knowledge and skills within Utility & solvents Generation & Distribution design. Join us in delivering the largest and most advanced pharmaceutical projects, while learning from some of the smartest people within process utilities. In the Process Systems Intelligence department, we are 20+ dedicated members working with Clean Utility, Black Utility, Process Waste, and CIP within the pharma & biopharma industry. We aim to inspire our customers with new technologies and help them find the optimal solutions when building new facilities, expanding, or renovating existing facilities. You will have the opportunity to explore new, smarter, and more sustainable technologies. As a specific initiative in our area, we have biweekly knowledge sharing activities where you learn from colleagues - examples hereof are: Digital twin, sustainability initiatives in a specific project, new technology within department connected to regulatory requirements, discussion with technology suppliers, and how to execute projects smarter. You will also get the opportunity to further grow your competencies through internal/external courses and conferences. Our office is in Bangalore, India and in Virum, Denmark where we have an open and flexible office environment, which provides space and opportunities for knowledge sharing, dialogue, and of course - to have fun. We also work from NNE s office in Kalundborg site and depending on current projects the workplace will be there or at customer site. Required Skill Set Excellent verbal and written communication skills with success in building trustful relationships and influencing others in cross-functional areas including customer management Experience in Pharma, Biotech industry is a must. Coordination with other disciplines & conducting design review for engineering activities. Have experience in the perform the Gemba / quality checks for the required discipline. Estimation of Generation Capacities for Utility (Clean, Black, CIP, Waste & Exhaust), Gases and solvents Prepare URS for Utility (Clean, Black, CIP, Waste & Exhaust), Gases and solvents generation skids/equipment & Distribution package Knowledge in Defining concept, designing, sizing and testing of clean & black utility systems and process gases & Solvents and distributions systems on both existing and new facilities. Experience with regulatory requirements, authority applications, GMP impact and calculation of energy consumption. optimization of design solutions to meet specific project technical & commercial requirements. Prepare, Evaluate & Finalize the tender for the utility & Solvents packages. Have experience in qualification of the vendor and equipment (validation life cycle) Have experience in Planning & Estimation of the project deliverables in the different phase of project. Preferred Competencies We care about who you are as a person. In the end, how you work, and your energy is what impacts the effort we do as a team. As a person, you: Are determined and have a solid customer understanding and a consultative mindset Have an interest in technological developments and trends in the field. Are an eager project member and are excited for solving complex tasks Able to collaborate and work with cross disciplinary. Understanding of your colleagues personal and cultural differences Fluent in English, spoken and written. Education and Work Experience In all positions there are some things that are needed, and others a bonus. We believe these qualifications are needed for you to do we'll in this role: BE / B. Tech or M.Sc. / ME / M. Tech in Mechanical, Chemical or equivalent, with relevant experience Must have experience in CD, BD, DD & Construction phases of project execution. Must have good knowledge of the current relevant Engineering & Pharma legislation / regulations / guidelines / standards. Knowledge/ work experience in MS VISIO, AUTO CAD, NAVISWORK are preferred.

Job Title: Manager-Plant Maintenance Block A Position: Manager-2 Job Grade: G11A No. of Direct Reports (if any): 09 Function: Engineering & Projects. Location: Dadra Areas of Responsibility 1. To ensure 100% Maintenance of all Plant Machinery process Equipments (Granulation equipments-FBD, FBE, RMG, Blender, Tablet compression machine, Tablet Coating machines, Blistering machine, Cartonating machines, Packing Bottle machines, Inspection machine etc.) & its relevant. Ensure minimum time for the breakdown to be achieved 2. To ensure technician & staff deputed at breakdown, preventive & building maintenance works accordingly as per approved shift schedule. 3. To ensure the timely completion of the work orders, purchase orders & purchase requisition & ensure the work measurements are proper and timely bill booking & approval from the Block Head. 4. To involve & support in the modification/ongoing CAPEX as well as projects works for the right implementation of the equipment to ensure right & easy maintenance of the same in future. 5. To ensure the services vendor at site & loading/unloading, fabrication & civil works are carried out as per the GMP norms with safety norms also. AMC if any should be inline as per schedule. 6. To train the people & people management & ensure all have to trained in LMS system as well as applicable OJT in place as per the requirements. 7. To ensure Preventive maintenance & Breakdown maintenance program through SAP system. All records & schedule should be traceable as per SOP. 8. To handle all the stakeholders for their works & timely maintenance solution to each with defined timeline. 9. To coordinate with EHS Department for statuary complies & ensure the safety maintenance. 10. To ensure the critical spares/inventory/hardwares to be available for the maintenance purpose. 24x7 shift management & availability of the manpower’s for the maintenance & rectification works. 11. Implementation of Good Engineering Practices, Good Manufacturing Practices, Data integrity and Good Documentation Practices should be followed & no any noncompliance. 12. To Co-ordinate the internal engineering cross function section like utility, calibration & water system for getting the rectification & timely works completion relevant to process equipment/APU. 13. To prepare the investigation, root cause identification and derive CAPA in case of incident of system failures/out of specification observation and request change control, action item through Track wise (QMS) system. 14. Handling of EDMS, LMS, track wise accordingly & input to be done for the smooth system handling & documents handling accordingly. 15. Co-ordinate for the self-inspection/visit/audit at site & ensure proper walkout for the same while inside the premises/ process equipment area. 16. To handle observations & ensure timely compliances of observations/points same within timeline. 17. To handle the vendor/OEM as per requirements & ensure the GMP compliances accordingly. 18. To ensure all required drawings/layouts of AUTO CAD generated & approved . Status label, record shall be in place & current updated version of the SOP. Drawings/layouts regarding plant equipment & APU system Job Scope Internal Interactions (within the organization) All departments stakeholders External Interactions (outside the organization) External service vendor like fabrication, building maintenance vendors etc. Geographical Scope Any. Financial Accountability (cost/revenue with exclusive authority) To run the maintenance as per defined budget & control the inventory Job Requirements Educational Qualification B.E. Electrical (Preferably). Specific Certification Should know AUTO CAD, PCS system knowledge & Projects skills will add advantages. Skills Good trainer on SOPs, Good mentor to technical staff Experience 10-15 Years.

Role & responsibilities Has Experience of Validation process . Experience of Process Validation Experience of Cleaning Validation Hands on experience of Creating and reviewing Protocol for Validation Preferred candidate profile Profile - Validation Total Experience - 3+ to 5 Yrs Qualification - Msc Chemistry

Role & responsibilities 1. Prepare the validation schedules for new projects, revalidation schedules for existing equipment/utilities as per respective procedures 2. Execute and review of all the qualification/re-qualification protocols and reports pertaining to equipment, utilities, instruments and facilities 3. Responsible to update or review Qualification, Production and engineering related procedures which are compliant to current GXP regulatory norms 4. Responsible for preparation of Validation master plan/Site master file Responsible for reviewing and ensuring all the scheduled activities for Preventive maintenance, filter cleaning, filter replacements, calibrations, Alarm/audit trail reports etc are performed as per the respective procedures within specified time Preferred candidate profile B Pharmacy/Msc Education qualification with 03 to 09 years experiance Perks and benefits Best in industry

Job Overview: Electrica Engineers India Pvt Ltd is seeking an experienced and highly motivated Sr. Executive Engineer in Process Engineering Department . Sr. Executive Engineer will be responsible for Designing, Optimizing, and Improving Manufacturing Processes, focusing on Efficiency, Quality, and Safety. Sr. Executive Engineer will be involved in Equipment Specification, Troubleshooting, Quality Control, and continuous improvement efforts to enhance overall production performance. The Sr. Executive Engineer will also play a key role in training production staff and ensuring compliance with Safety and Regulatory Standards. Key Responsibilities: Design and Optimization: Design and optimize the layout and setup of manufacturing equipment and processes. Apply mathematical models, simulations, and hands-on experimentation to ensure production processes are efficient, of high quality, and capable of meeting throughput targets. Process Analysis: Continuously analyses and monitor manufacturing processes to identify bottlenecks or inefficiencies. Use analytical tools and techniques to make data-driven decisions that enhance productivity and product quality. Equipment Specification: Specify requirements for process equipment and machinery, ensuring they meet the necessary production capacity and quality standards. Collaborate with equipment suppliers to customize machinery for specific manufacturing tasks. Quality Control: Develop and implement rigorous quality control protocols to ensure the consistency and quality of the final product. Work with quality assurance teams to maintain product compliance with industry standards and customer specifications. Safety and Compliance: Ensure that all manufacturing processes adhere to safety guidelines, environmental regulations, and industry standards. Conduct risk assessments and develop safety procedures to protect workers, equipment, and the environment. Cost Reduction: Identify opportunities for cost-saving measures without compromising quality. Recommend more efficient materials, streamlined production processes, or the introduction of energy-saving technologies. Troubleshooting: Take a lead role in diagnosing and resolving production issues. Troubleshoot equipment malfunctions, process failures, or product defects using technical expertise and problem-solving skills. Training: Provide training to production staff on new processes, equipment, and safety protocols. Ensure that all team members are knowledgeable, competent, and confident in their roles, contributing to a smooth and safe operation. Requirements: Educational Background: B.E/B. Tech in Mechanical, Industrial Engineering, or a related field. Experience: 5-8 years of experience in process engineering, preferably within a manufacturing or production environment. Technical Skills: Strong knowledge of process design, process optimization, equipment specification, and quality control. Proficient in using engineering analysis tools and process management software. Problem-Solving Abilities: Strong troubleshooting skills with the ability to identify issues and implement effective solutions. Communication Skills: Excellent communication skills, with the ability to work closely with cross-functional teams and present technical information clearly. Software Proficiency: Familiarity with process simulation software and CAD tools is preferred. Preferred Qualifications: Experience in continuous improvement methodologies, such as Lean Manufacturing or Six Sigma. Knowledge of regulatory standards and industry-specific safety protocols. Experience in cost analysis and cost-saving initiatives in manufacturing processes. Capabilities & Desired Characteristics: Detail-Oriented: Exceptional attention to detail to ensure high-quality standards. Analytical Thinking: Strong analytical skills for troubleshooting and optimizing processes. Team Collaboration: Ability to collaborate with various teams, including quality assurance, maintenance, and production, to achieve company objectives. Professionalism: High level of professionalism, responsibility, and commitment to meeting project deadlines and quality standards. Employee Benefits- 1. Comprehensive Health Insurance : We prioritize the well-being of our team by offering comprehensive health coverage, ensuring peace of mind for you and your family. 2. Professional Development Opportunities : At Electrica, we believe in continuous learning. We provide access to training programs, workshops, and certifications to help you grow in your career. 3. Work-Life Balance Support : We promote a healthy work-life balance through flexible working hours and paid time off, ensuring you have time to recharge and focus on what matters most.

Responsible perform/Report the analysis of Water and pure steam (Condensate) samples. Responsible for preparation of Standard operating procedures, Standard test procedures, specifications ,SOP, STP, Specification, ATDS CoA of the RM, PM, Consumable Required Candidate profile change control /deviation / OOS / OOT / OOC/CAPA. Analytical method transfer/Stability Protocols Report the analysis of Finished Product, In- IP, SFG, FP. Perform the analysis as or when required

Role & responsibilities BE/BTech in Mechanical/Electrical/Instrumentation/Industrial Production Engineering with around 1 to 2 years of experience and knowledge of process, process equipment and utilities of pharmaceutical manufacturing industry. Candidate must have basic knowledge of GMP (Good Manufacturing Practices) requirements in the manufacturing environment of formulation facilities (both solid orals & sterile injectables). Candidate must know about requirement of documentation and preparation of GMP documents and should be willing learn and carry out independently with assistance. Job Description: Preparation of URS for process equipment and clean utilities Preparation of SOPs Qualification documentation Validation protocols Risk assessment & mitigation plan Preparation of GMP layouts using AutoCAD Preparation of people & material flow Preparation of waste flow and knowledge of waste handling Preparation of concept note for designing of HVAC system and layouts for classification, Zoning and Differential pressure (DP). Preparation of URS for manufacturing facility Root cause investigation and preparing reports.