Invitation to Interview Drive at Laurus Bio Greetings from Laurus Bio. We are pleased to invite you to our upcoming Interview Drive for multiple positions in our Engineering & Projects Team at Bangalore/Vizag/Tumkur Location. Interview Drive Details: Date: Saturday 23rd August 2025 (Bangalore) Time: Between 9:00 AM 12:00 PM Location: PLOT NO. 204 AND 237, BOMMASANDRA-JIGANI LINK ROAD KIADB INDUSTRIAL AREA, JIGANI HOBLI, ANEKAL TALUK, BANGALORE KA 560105. https://www.google.com/maps/dir/12.7991808,77.6634368/laurus+bio+jigani/@12.7953921,77.6567234,16z/data=!3m1!4b1!4m9!4m8!1m1!4e1!1m5!1m1!1s0x3bae6d5e652e52b3:0xfd81a98fb8fedaa3!2m2!1d77.6598457!2d12.7900612?entry=ttu Role: In Projects & Engineering Field of Education: Chemical/ Mechanical/Civil/Electrical Engineering (Degree/Diploma) Experience: Minimum 2 Years Maximum 5 Years Mode: In-person Kindly bring an updated printed copy of your resume and any other required documents. We look forward to meeting you and discussing how you can be a valuable part of our team. Best regards, Laurus Bio Team
Role & responsibilities Independently handle project from concept, costing, project proposal, client coordination up to project delivery by ensuring coordination with all the internal stake holders & end customers within timeline. Overseeing the planning, design, and construction of capital projects. Preparing a project plan with clear deliverables, timelines, dependencies and critical path. Work in partnership with stakeholders using various project management tools to plan, report and control project timelines and budget Reporting of any issues/challenges and timely escalation to ensure project objectives are not hindered Monitoring project progress and producing regular reports and MIS for senior management Experience in Project Management in Capital projects. PMP certified, MSP proficiency Must have skills : PMP certified, Microsoft Project and Training, Project Planning, Agile Project Management, Microsoft Project, Green/ Brown field project experience
Position Title Executive/ Sr. Executive Education Bachelor of Engineering –Electronics and instrumentation/ Instrumentation and control/ Electrical and electronics/ with relevant industrial instrumentation experience Diploma – Instrumentation and control ,Electrical and Electronics, Electronics and communication engineering with relevant industrial instrumentation experience Years of experience : Min 3 Years - Max 7 Years Industry: preferably - biotech/pharma/Food and beverages Roles and Responsibility: Handling of Fermenter instruments like pH, DO, Pressure transmitters, Temperature transmitters Calibration of instruments Basic exposure in HPLC, Chrome system, Lyoplizers, Fermenters, Reactors Knowledge of instruments like flow meters, pressure sensors, and temperature controllers, Temperature gauges, Pressure Gauges Handling of VFD – ABB, Siemens. Danfoss Knowledge in PLC, DCS, HMI and SCADA control systems Preventive maintenance and calibration of instrumentation Preventive maintenance of UPS Knowledge in GMP (Good Manufacturing Practice) and GxP standards. Maintaining detailed records of calibration, maintenance, and system changes Temperature mapping studies Validation of equipment and instruments Understanding of pharmaceutical regulations and cleanroom protocols Knowledge QMS, CC, Risk assessment, Deviation closure Basic knowledge in SAP Willing to work in shift Must have skills : Handling of instrumentation and related documentation with minimum of 3 Yrs of experience
Roles & Responsibility This role has more of a hands-on approach with tasks and communication involved with cross-functional teams. Should have excellent Communications skills. Must have good soft skills to aid in the preparation of internal presentations and slide decks for management. Supporting project team to ensure projects stay on track w.r.t timeline. Collect and Analyze data to support project-decision making. Educational Background: Pursuing an MBA with Mechanical engineering background. B.Tch/ M.Tech Mechanical Engineer Highly preferred Project management experience preferred. Experience: Freshers
Position: Automation & Instrumentation Executive/Sr Executive/ DM/AM Experience: 5 Years - 16Years Department: Engineering & Maintenance / Projects Role Summary We are seeking a highly skilled and experienced Automation & Instrumentation professional with 10+ years of expertise in maintenance, troubleshooting, project execution, and commissioning . He will be responsible for ensuring the reliable operation of automation and instrumentation systems, leading maintenance activities, and supporting project implementation across LB4 Vizag Facility Key Responsibilities Maintenance: Ensure smooth operation and maintenance of field instrumentation, PLCs, DCS, SCADA, control valves, Flow meters, Pressure Instruments, Liquid Analysers, Discrete switches, Temperature Instruments and sensors. Troubleshoot and resolve breakdowns in automation and control systems. Implement predictive and preventive maintenance programs for instrumentation systems. Candidate should be able to work in shifts. Calibration of Field Instruments, Planner, Resource allocation and Documentation with regulatory standards. Trouble shooting of VFD and Its circuits. Projects: Candidate should Lead automation & instrumentation projects including design, engineering, installation, testing, and commissioning. Prepare technical specifications, BOQs, and review vendor proposals. Coordinate with contractors, OEMs, and internal teams to ensure timely project completion. Support plant expansion/modification projects with automation and digitalization initiatives. Compliance & Documentation Ensure compliance with safety, quality, and regulatory requirements (cGMP, FDA, ISO, etc., if pharma/chemical). Prepare and maintain documentation including SOPs, user manuals, and project records. Manage instrument validation, FAT, SAT, and qualification protocols. Procurement. Planning and maintain the spare requirement for all the I&A components Should be able to indent the required spare. Vendor /Supplier discussions and the get the quotations. Team Management Lead and mentor junior engineers and technicians in automation and instrumentation. Coordinate with cross-functional teams (Production, Quality, IT, Utilities, Projects) to ensure operational excellence. Drive continuous improvement initiatives and adoption of Industry 4.0 technologies. Key Skills & Competencies Knowledge of PLC/DCS/SCADA systems (e.g., Siemens, Rockwell, ABB, DeltaV). Hands-on experience in industrial communication protocols (Profibus, Profinet, Modbus, Ethernet/IP, OPC, etc.). Strong troubleshooting, problem-solving, and root cause analysis skills. Familiarity with pharma plant like, Fermentation Upstream and downstream, Utility and BMS. Project management skills including planning, budgeting, and execution. Qualifications B.E. / B.Tech/Diploma. in Instrumentation, Electronics and Communication. 10+ years of experience in Automation & Instrumentation with both maintenance and project exposure.
Position Title Research Associate / Sr. Research Associate USP Fermentation Education M.Sc. / M. Tech in Biotechnology, Biopharma, Microbiology, or Life sciences. Years of Experience Min 1 Years Max 7 Years Industry – Preferably Biotech / Pharma / Industrial Fermentation Key Skills : microbial fermentation (E. coli & Yeast), bioreactor operation, GMP/GLP/GDP practices, SOP preparation, media preparation, CIP/SIP, Aseptic handling, Inoculum preparation. Roles and Responsibilities – Execution of upstream fermentation processes across bacterial, yeast, and/or plant platforms, ensuring robust operation and compliance with protocols. 1. Fermentation Execution Operate fermenters (2L–150L) for bacterial, yeast, fungal, actinomycetes, and plant cell cultures. Handle both recombinant and native expression systems. Execute batch, fed-batch, and high cell density fermentations. Prepare and sterilize media tailored to organism and process type. Perform inoculum development, cascading, and aseptic transfers. 2. Equipment & Process Readiness Prepare fermenters and associated systems (CIP/SIP, calibration, leak checks). Ensure readiness of utilities (steam, air, water) and monitor critical parameters (pH, DO, temperature, agitation, aeration). Troubleshoot basic equipment and process issues. 3. Documentation & Compliance Maintain accurate batch records, logbooks, and daily activity sheets. Follow SOPs and ensure adherence to EHS and GLP guidelines. Support internal audits and inspections. 4. Support Activities Assist in raw material preparation and inventory tracking. Coordinate with downstream team for biomass handover. Participate in training and continuous improvement initiatives.
Position Title: Assistant Manager / Deputy Manager USP Fermentation Education M.Sc. / M.Tech in Biotechnology, Microbiology, Biochemical Engg., or related field. Years of Experience Min 8 Years Max 10 Years Key Skills : microbial fermentation, bioreactor operation, GMP/GLP/GDP practices, SOP preparation, media preparation, CIP/SIP, Aseptic handling, Inoculum preparation, process scale-up & scale-down Industry Preferably Biotech / Pharma / Industrial Fermentation / Food & Beverages Roles and Responsibilities – Lead and manage upstream fermentation operations across diverse platforms, ensuring efficient planning, execution, documentation, and team coordination. 1. Fermentation Oversight Manage fermentation batches across 2L–150L scale for native and recombinant expression systems. Troubleshoot deviations and optimize fermentation parameters for yield and productivity. 2. Planning & Coordination Prepare shift schedules and batch plans aligned with production timelines. Coordinate with cross-functional teams for seamless operations. Ensure resource availability and efficient utilization. 3. Documentation & Reporting Draft and review SOPs, protocols, and batch records. Prepare technical reports, presentations, and data summaries. Analyse fermentation data for trends, deviations, and process improvements. 4. Team Management & Training Lead and mentor RA/SRA and technical staff. Conduct training on fermentation techniques, safety, and compliance. Foster a culture of accountability, learning, and continuous improvement. 5. Compliance & Audit Readiness Ensure adherence to GLP, EHS, and internal quality standards. Support audits and implement CAPAs as required.
Position Title Research Associate / Sr. Research Associate - USP Fermentation Education M.Sc. / M. Tech in Biotechnology, Microbiology, Biochemical Engg., or related field. Years of Experience Min 3 Years – Max 7 Years Industry – Preferably Biotech / Pharma / Industrial Fermentation Key Skills : microbial fermentation, bioreactor operation, GMP/GLP/GDP practices, SOP preparation, media preparation, CIP/SIP, Aseptic handling, Inoculum preparation, process scale-up & scale-down Roles and Responsibilities – Execution of upstream fermentation processes across bacterial, yeast, and/or plant platforms, ensuring robust operation and compliance with protocols. 1. Fermentation Execution Operate fermenters (2L–150L) for bacterial, yeast, fungal, actinomycetes, and plant cell cultures. Handle both recombinant and native expression systems. Execute batch, fed-batch, and high cell density fermentations. Prepare and sterilize media tailored to organism and process type. Perform inoculum development, cascading, and aseptic transfers. 2. Equipment & Process Readiness Prepare fermenters and associated systems (CIP/SIP, calibration, leak checks). Ensure readiness of utilities (steam, air, water) and monitor critical parameters (pH, DO, temperature, agitation, aeration). Troubleshoot basic equipment and process issues. 3. Documentation & Compliance Maintain accurate batch records, logbooks, and daily activity sheets. Follow SOPs and ensure adherence to EHS and GLP guidelines. Support internal audits and inspections. 4. Support Activities Assist in raw material preparation and inventory tracking. Coordinate with downstream team for biomass handover. Participate in training and continuous improvement initiatives.
Document Issuance and Control: Issue annexures, BMRs, BPRs, SOPs, and logbooks for CFTS as necessary to ensure compliance and operational efficiency. Archival and Retrieval of Documents: Archive completed documents from CFTs and ensure easy traceability through effective retrieval procedures. SOP Preparation: Prepare departmental Standard Operating Procedures (SOPs) as needed to ensure compliance and operational efficiency. Master List Maintenance: Maintain and update the master list of documents and records. Annual Product Review: Prepare comprehensive annual product reviews to assess the consistency and quality of manufactured products. Document and Sample Upkeep: Ensure the proper upkeep, retention, and stability testing of documents and samples. Audit Support: Assist in the timely retrieval of documents during audits and post-audit, to ensure archival of documents in respective cabinets. QMS Tracking: Maintain the tracking with the completion of QMS Documents in coordination with the CFTS. Training: Scheduling & coordinating for the On-the-job trainings of the department. To ensure the On-the-job trainings are in place. Work Discipline: Maintain strict adherence to work discipline and company policies.
Position Title Executive/ Senior Executive (Projects) Education - B.E/B.Tech/Diploma- Mechanical Engineering with relevant experience in Process Industry handling Plant maintenance. Years of experience : Min 3 Years - Max 7 Years Industry: preferably - Biotech/pharma/Food and beverages Roles and Responsibility: Handling of Fermentation plant include both Upstream and downstream. 1 . Upstream (Fermentation Systems): Breakdown & Preventive maintenance and troubleshooting of fermenters, dosing vessels, media preparation tanks . Mechanical upkeep of agitators, seals, jackets, valves, and piping. 2. Downstream (Separation Systems): Breakdown & Preventive maintenance and troubleshooting of centrifuges, filter presses, Homogenizer. Regular monitoring of wear parts (bearings, seals, filters) and planning replacements. Troubleshoot vibration, imbalance, and alignment issues in rotating equipment. 3. Filtration Systems: Breakdown & Preventive maintenance and troubleshooting of Microfiltration (MF) and Ultrafiltration (UF) skids. 4. Drying Systems: Breakdown & Preventive maintenance and troubleshooting of Lyophiliser, drum dryers, spray dryers, blowers, and rotary systems . Plan spare parts availability to reduce drying process downtime. 5. Water Generation & Distribution Systems: Breakdown & Preventive maintenance and troubleshooting of RO units, purified water generation systems, storage tanks, and distribution loops . Handle pumps, piping, valves, and skid maintenance as per GMP requirements. Coordinate with quality for ensuring compliance to water system standards. 6. General Maintenance: Plan preventive and predictive maintenance schedules . Maintain equipment history cards, and GMP documentation. Coordinate with vendors and OEMs for AMC/spare parts support. Ensure adherence to safety, GMP, and statutory norms during maintenance activities. Qualification of equipment Knowledge QMS, CC, Risk assessment, Deviation closure Basic knowledge in SAP Willing to work in shift
Position Title Assistant Manager/ Deputy Manager (Projects) Education - B.E/B.Tech/Diploma- Mechanical Engineering with relevant experience in Process Industry handling Plant maintenance. Years of experience : Min 10 Years - Max 15 Years Industry: preferably - Biotech/pharma/Food and beverages Roles and Responsibility: Handling of Fermentation plant include both Upstream and downstream. 1 . Upstream (Fermentation Systems): Breakdown & Preventive maintenance and troubleshooting of fermenters, dosing vessels, media preparation tanks . Mechanical upkeep of agitators, seals, jackets, valves, and piping. 2. Downstream (Separation Systems): Breakdown & Preventive maintenance and troubleshooting of centrifuges, filter presses, Homogenizer. Regular monitoring of wear parts (bearings, seals, filters) and planning replacements. Troubleshoot vibration, imbalance, and alignment issues in rotating equipment. 3. Filtration Systems: Breakdown & Preventive maintenance and troubleshooting of Microfiltration (MF) and Ultrafiltration (UF) skids. 4. Drying Systems: Breakdown & Preventive maintenance and troubleshooting of Lyophiliser, drum dryers, spray dryers, blowers, and rotary systems . Plan spare parts availability to reduce drying process downtime. 5. Water Generation & Distribution Systems: Breakdown & Preventive maintenance and troubleshooting of RO units, purified water generation systems, storage tanks, and distribution loops . Handle pumps, piping, valves, and skid maintenance as per GMP requirements. Coordinate with quality for ensuring compliance to water system standards. 6. General Maintenance: Plan preventive and predictive maintenance schedules . Maintain equipment history cards, and GMP documentation. Coordinate with vendors and OEMs for AMC/spare parts support. Ensure adherence to safety, GMP, and statutory norms during maintenance activities. Qualification of equipment Knowledge QMS, CC, Risk assessment, Deviation closure Basic knowledge in SAP Willing to work in shift
Storng Experiencei in EHS domain. Designing and development of EHS training program. safety promotion activities Conduct safety inspections / audits, Machine guarding activities Qualified 14001 & 45001 internal auditor Should have experience in managing ISO 14001 & ISO 45001 audit and documentation activites. Should have lead sustainability project Knowledge in ESG. Sound knowledge in HIRA, HAZOP, QRA etc., Sound knowledge in liasoning with KSPCB, inspector of factories,
Job Title: Scientist Downstream R&D Job Summary: We are looking for a Scientist Downstream R&D to lead the development and optimization of protein purification processes. The role involves chromatography, ultrafiltration, filtration, and process scale-up to ensure efficient and scalable downstream processing. The candidate will collaborate with cross-functional teams to support process development, technology transfer, troubleshooting, and regulatory documentation. Qualifications: Masters in Biotechnology, Biochemistry, or a related field with 8-10 years of industry experience. PhD in Biotechnology, Biochemistry, or a related field with 4- 6 years of industry experience. Roles & Responsibility: Technical Expertise: Extensive experience in protein purification, chromatography (KTA), ultrafiltration, and TFF. Strong understanding of bioprocess engineering, process scale-up, and automation. Soft Skills: Analytical mindset, problem-solving ability, and strong collaboration skills. Preferred: Experience with DOE, statistical analysis, and high-throughput screening is a plus. Key Responsibilities: Protein Purification & Process Development: Develop and optimize chromatography-based purification (affinity, ion exchange, size exclusion), ultrafiltration, and filtration techniques. Design and execute experiments for process characterization, yield improvement, and cost efficiency. Implement high-throughput screening and automation-based purification strategies. Scale-Up & Technology Transfer: Lead process scale-up from laboratory to pilot and manufacturing scales. Support technology transfer, process validation, and regulatory documentation. Process Characterization & Troubleshooting: Investigate process deviations, troubleshoot purification challenges, and implement corrective actions. Enhance process robustness and reproducibility through optimization studies. Regulatory Compliance & Documentation: Maintain detailed experimental records, write technical reports, and contribute to cGMP, ICH, FDA regulatory documentation. Collaboration & Cross-Functional Interaction: Work closely with Upstream, Analytical, and Formulation teams to ensure smooth process integration. Participate in cross-functional discussions to drive efficiency and innovation. Process Optimization & Innovation: Apply Design of Experiments (DOE) and statistical analysis for process development. Explore new purification strategies, automation, and continuous processing techniques.
Roles and Responsibilities We are looking for a highly innovative professional for our project management team. In this role you will be responsible for wing-to-wing execution of CDMO/CRO projects to deliver high quality outcomes to internal and/or external customers. Specifically, you will: Manage multiple projects concurrently from initiation through execution and closure. Develop and maintain individual and comprehensive project plans and schedules. Identify project risks and develop risk mitigation plans. Develop and manage project scopes, change requests, and project deliverables. Monitor project progress and ensure adherence to project schedules and budgets. Collaborate with internal and external stakeholders to ensure project success. Provide regular communication to stakeholders, ensuring thoroughness in dealing with the details. Develop and maintain strong relationships with project stakeholders. Ensure that projects meet quality standards and regulatory requirements. Qualifications Masters/Ph.D (Life Sciences/ Microbiology or related disciplines) Masters + 3-5 years of work experience; PhD with 0-3 years experience Knowledge of/ experience in fermentation-based manufacturing will be an added advantage. Take initiative, being willing to work in a fast-paced environment with demonstrated capacity to handle multiple tasks and demands. Ability to effectively work in cross-functional teams and manage multiple workflows Strong communication skills to interact with internal and external stakeholders
Person should be a graduate with working Experience in Warehouse Responsible for Inventory & Dispensing activity Able to troubleshoot the Challenges and Audit queries Co-ordination with all CFTs for all the activities. Prepare/Review SOPs and Checklists in coordination with QA team. Follow cGMP procedures and safety regulations in the Warehouse / Plant Inputs provided to optimize the process and increase the efficiency Adherence to Quality and safety standards Alignment to companys core values
Person should be a Postgraduate with working Experience in Warehouse Responsible for Inventory Accountability & overall activities Capable of resolving audit questions and challenges Assist with all CFTs for all the activities. Review SOPs and Checklists in as per norms with QA team. Verify cGMP procedures and safety regulations in the Warehouse / Plant Able to optimize the process and increase the efficiency Adherence to Quality and safety standards Alignment to companys core values
Manage calendars, schedule meetings, and coordinate travel arrangements Prepare reports, presentations, and correspondence Handle confidential information with discretion Liaise with internal departments and external stakeholders Organize and maintain files and records Assist in planning and executing company events and meetings Track and follow up on action items and deadlines Provide administrative support for special projects
Role & responsibilities : 1) Sampling and testing of Raw material, Packaging material, in process samples and finished products as per specification and standard testing procedure. Testing of water samples as per defined sampling frequency. 2)Preparation of laboratory reagents and volumetric solutions required for chemical analysis in the laboratory. 3) Preparation of SOP (standard operating procedures), EOP (equipment operating procedures), protocols, STP (standard testing procedures) and specifications for the in-process samples and finished products as per customer requirement. 4) Calibration of the laboratory instruments as per the equipment operating procedures. 5) Appropriate record keeping including logbooks, calibrations record etc. in the laboratory. 6) Initiate OOS, change controls, deviations, and incidents as applicable in the laboratory. 7) Preparation of COA (Certificate of Analysis) for the finished products and COT (Certificate of Testing) as applicable for the in-process samples dispatch to customers. 8) Upkeep of instruments and equipment in the Laboratory as per cGMP and GLP requirements. Procurement of chemicals, consumables, and analytical instruments spares as per analytical requirements. 9)Preparation of Method verification/validation protocol and report as required. 10) Analysis of Method validation, process validation and cleaning validation samples as required. 11) Participate in internal audits. To facilitate regulatory and customer audits with respect to Quality Control Laboratory 12) Following and adhering to GMP and GDP guidelines. 13) Implementation of food safety management system in the laboratory and adherence to the hygiene requirements. 14) To report food safety incident, any contamination, deviation from policy to food safety team at site.
Job Summary: The Production Shift In-Charge USP is responsible for leading and supervising all upstream production activities during the assigned shift. This includes overseeing Microbial / mammalian operations, ensuring compliance with cGMP and safety standards, managing manpower, and ensuring smooth execution of the batch as per the production schedule and approved procedures. Role & responsibilities 1. Shift Operations Management Supervise and coordinate all upstream (USP) production activities during the shift, including media preparation, seed train, bioreactor operations, and harvest. Ensure adherence to batch manufacturing records (BMR), SOPs, and GMP guidelines. Monitor and record all process parameters (pH, DO, temperature, agitation speed, etc.) and ensure deviations are promptly reported and documented. Review shift logbooks and ensure proper handover between shifts. 2. Team Leadership & Training Lead, guide, and supervise operators, executives, and technicians in the USP area. Allocate manpower and ensure optimal utilization of resources during the shift. Train team members on cGMP, aseptic techniques, and safe handling of equipment and materials. 3. Equipment & Process Management Ensure availability, cleanliness, and readiness of all USP equipment (bioreactors, autoclaves, incubators, fermenters, etc.). Oversee CIP (Clean-In-Place) and SIP (Sterilize-In-Place) operations. Coordinate with Engineering for preventive maintenance, calibration, and troubleshooting of equipment. Verify line clearance before initiating batch operations. 4. Compliance & Documentation Ensure that all operations comply with cGMP, EHS, and company policies. Review batch records, logbooks, and cleaning records for completeness and accuracy. Report deviations, non-conformances, and ensure timely initiation of CAPA. Participate in internal and external audits as a process representative. 5. Coordination & Communication Collaborate with QA, QC, Downstream Processing (DSP), and Warehouse teams for smooth batch execution. Communicate critical issues, process alarms, or safety incidents to the Production Manager immediately. Participate in daily production meetings and contribute to process improvements. Preferred candidate profile Key Competencies: Leadership and team management skills. Strong problem-solving and decision-making ability. Excellent communication and documentation skills. Attention to detail and commitment to compliance. Ability to work in rotating shifts and under pressure.
Job Summary: The Production Shift In-Charge DSP is responsible for leading all downstream processing operations during the assigned shift to ensure consistent, efficient, and GMP-compliant production of biological products (e.g., monoclonal antibodies, vaccines, recombinant proteins). The role involves supervising the purification process, managing manpower, ensuring equipment readiness, and maintaining quality and safety standards. Role & responsibilities Key Responsibilities: 1. Shift Operations Management Supervise all downstream production activities, including harvest, filtration, chromatography, ultrafiltration/diafiltration (UF/DF), and formulation. Ensure batch manufacturing records (BMRs) are followed strictly as per approved procedures and cGMP guidelines. Monitor process parameters (flow rates, pressures, conductivity, pH, temperature, etc.) and record data accurately. Perform in-process checks and ensure timely sampling and coordination with the QC team. Oversee batch changeovers and line clearances between operations. 2. Team Leadership & Training Lead, train, and supervise production executives, operators, and contract staff during the shift. Allocate manpower effectively to ensure smooth workflow and timely batch execution. Conduct on-the-job training for team members on GMP, safety, and equipment operation. 3. Equipment & Process Management Ensure readiness, cleaning, and sterilization of all DSP equipment (e.g., chromatography skids, TFF systems, centrifuges, filtration units, mixers). Oversee CIP (Clean-in-Place) and SIP (Sterilize-in-Place) activities. Coordinate with Engineering for equipment maintenance, calibration, and troubleshooting. Review equipment logs and ensure timely updates in line with GMP compliance. 4. Documentation & Compliance Review and verify batch records, logbooks, and cleaning records for accuracy and completeness. Ensure compliance with cGMP, GDP (Good Documentation Practices), EHS (Environment, Health & Safety), and company quality standards. Identify and report deviations, non-conformances, and assist in root cause analysis and CAPA implementation. Support internal and external audits and provide necessary process documentation. 5. Coordination & Communication Collaborate with Upstream (USP), QA, QC, Warehouse, and Engineering teams for coordinated production activities. Communicate critical process issues, equipment alarms, or safety incidents promptly to the Production Manager. Participate in daily production review meetings and contribute to process optimization initiatives. Preferred candidate profile Key Competencies: Leadership and team management. Strong analytical and troubleshooting abilities. Excellent communication and documentation skills. Focus on quality, safety, and regulatory compliance. Ability to work effectively in a 247 shift environment.