This position shall perform commissioning and qualification of pharmaceutical equipment, including any or all of systems for Oral Solid Dosage, Equipment’s like RMG, CoMil, Tablet press, Coating Machine, blister packing machine, Responsibilities Develop CQMP, VMP, FRA, cGMP review sheet, interdependence Develop System boundary, URS, SCA/SLIA, CLIA, DQR, SRA/QRA, SAT protocol, commissioning protocol, IQ protocol, OQ protocol, PQ protocol. Develop process validation and cleaning validation protocol Execute Commissioning, qualification and validation activities for Pharma Process Equipment’s for OSD. Review, analyze and interpret system performance data for completed validation and prepare final report packages by summarizing the data. handling of deviation/ discrepancy, Investigation , CAPA . Promote cGMP and regulatory compliance into assigned projects. Exercise GDP, ALCOA, practice while execution. Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Hands on Experience with Pharma Process Equipment’s. Drafting of equipment operation SOP’s Qualifications & Other Requirements BS/MS in Engineering (Chemical, Pharma). 4-10 years in validation, quality systems, operations, engineering or any combination thereof. Experience in multiple GMP validation disciplines with advanced technical knowledge. Validation experience using, traditional, risk based, Hybrid approach. Knowledge of Validation Lifecycle approach (URS, FRS, FAT/SAT, Commissioning IQ, OQ, & PQ Protocols, etc.) guidelines, international regulatory requirements and standards. Experience working with Documentum or Maximo a plus. Experience interacting with or creating material for representatives of regulatory agencies and executive level staff. Experience with investigations into manufacturing deviations and determination of product impact potential, root cause and corrective actions. Strong verbal and written communication skills; excellent organizational and time utilization skills Ability to work independently and within project teams. Industry experience related to cGMP drug manufacturing, validation, and chemical process design Strong computer knowledge including Microsoft Office products Valid International passport without any legal obligations in terms of obtaining visa and should be willing to travel Show more Show less
Position: Automation & CSV Engineer Responsibilities 5+ years of experience in a Computer Systems Validation role in a Pharma, biopharmaceutical manufacturing environment. Facilities, Utilities, and Equipment (FUE) qualification Unit operations automation qualification with Honeywell, Delta V, and PLC-based systems Computerized systems validation Support to change controls, investigations, deviations, and CAPAs Technical understanding and experience of automation platforms, such as DeltaV, Emerson, Honeywell, Rockwell PLC, Siemens XFP Ability to effectively lead validation projects, coordinate contractors, junior level personnel and drive results Working closely with the systems integrators, automation leads & process leads Completing the FAT, SAT's, IQ, OQ. creating and executing the protocols & documentation Knowledge of E2500,V Model concepts along with GAMP5, S88,S95 Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for GMP regulated environments Must be able to solve routine problems with assistance. Strong organizational skills, excellent writing and communications skills Proficiency with Microsoft office including Word, Excel, and PowerPoint. Microsoft Project and Visio a plus Ability to travel up to 50% or more within and outside India Knowledge of Delta-V DCS systems, Rockwell qualification Knowledge of PI Historian. Large scale project experience. Valid Passport with no restrictions to travel any geography Education Engineering degree in Chemical, Automation, Biotechnology, EEE.
Position: CQV Engineer — EMS and BMS Room Location: India This position shall perform commissioning and qualification of EMS and BMS Systems in Pharma/Biopharma Facilities. Responsibilities Develop URS, risk assessment, system impact assessments, validation plans, protocols and reports that support the qualification and validation of systems. Develop and execute Commissioning and validation of EMS and BMS Systems Preparation of System Boundaries, SLIA, CLIA, QRA, Design Qualification Report, Traceability Matrix ,Facility Risk Assessments Develop Protocols and Execute test plans for BMS and EMS Systems. Perform IO Testing ,Control Logics Verification of DDC/PLC and SCADA /Software Testing. Software Verification – SCADA GUI, Reports, Control Access and Security Policies, Power Failure and Communication Failure, Audit Trail Verification, Alarms and Interlocks, Data Backup and Restoration, Control Logics. Perform walkdowns with wiring diagram, P&ID’s and System Architecture ,Air Flow drawings. Knowledge on the system architectures of BMS and EMS . Knowledge on Control logics for T RH, DP, Air flow and Fire Damper ,Smoke and other interlocks in BMS System. Good knowledge of field instruments and devices and their functionality like Temperature and RH transmitters, Level transmitters, Flow meters, Velocity Sensors, control valves, Differential pressure transmitters, Smoke Sensors etc. Verify the instruments calibration reports. Hands on experience in commissioning of other ELV Systems such as Door Interlocks, Access controls ,Fire Alarm Systems etc. Review, analyze and interpret system performance data for completed validation and prepare final report packages by summarizing the data. Investigate deviations, write investigation reports and propose corrective and preventive actions and create summary reports. Promote cGMP and regulatory compliance into assigned projects. Knowledge of GAMP ,EU Annexure 11 and US FDA 21 CFR 11 Guidelines . Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Qualifications & Other Requirements BS/MS in Electronics and Communications Engineering. 4-10 years in validation, engineering ,quality systems, operations, or any combination thereof. Experience in multiple GMP validation disciplines with advanced technical knowledge. Validation experience using , traditional, risk based, Hybrid approach. Knowledge of Validation Lifecycle approach (URS, FRS, FAT/SAT, Commissioning IQ,OQ,& PQ Protocols, etc.) guidelines, international regulatory requirements and standards and other in. Experience working with Documentum or Maximo a plus. Experience interacting with or creating material for representatives of regulatory agencies and executive level staff. Experience with investigations into deviations and determination of product impact potential, root cause and corrective actions. Strong verbal and written communication skills; excellent organizational and time utilization skills Ability to work independently and within project teams. Industry experience related to cGMP drug manufacturing, validation. Strong computer knowledge including Microsoft Office products Valid International passport without any legal obligations in terms of obtaining visa and should be willing to travel
This position shall perform commissioning and qualification of Pharmaceutical equipment, including any or all of systems for Oral Solid Dosage, Injectables, Fill/Finish. Equipment’s like RMG, CoMil, Tablet press, Coating Machine, blister packing machine, Vial Filling Line, PFS Line, Isolators (Negative & Positive), RABs (Open and Closed), GL Reactors, Dryer, Nutsche Filters, Centrifuges, Lyophilizers, etc Responsibilities Develop CQMP, VMP, FRA, cGMP review sheet, interdependencies Develop System boundary, URS, SCA/SLIA, CLIA, DQR, SRA/QRA, SAT protocol, commissioning protocol, IQ protocol, OQ protocol, PQ protocol. Develop process validation and cleaning validation protocol Execute Commissioning, qualification and validation activities for Pharma Process Equipment’s for API, Fill/Finish and OSD. Review, analyze and interpret system performance data for completed validation and prepare final report packages by summarizing the data. handling of deviation/ discrepancy, Investigation , CAPA . Promote cGMP and regulatory compliance into assigned projects. Exercise GDP, ALCOA, practice while execution. Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Hands on Experience with Pharma Process Equipments. Drafting of equipment operation SOP’s Qualifications & Other Requirements BS/MS in Engineering (Chemical, Pharma). 4-10 years in validation, quality systems, operations, engineering or any combination thereof. Experience in multiple GMP validation disciplines with advanced technical knowledge. Validation experience using , traditional, risk based, Hybrid approach. Knowledge of Validation Lifecycle approach (URS, FRS, FAT/SAT, Commissioning IQ, OQ, & PQ Protocols, etc.) guidelines, international regulatory requirements and standards. Experience working with Documentum or Maximo a plus. Experience interacting with or creating material for representatives of regulatory agencies and executive level staff. Experience with investigations into manufacturing deviations and determination of product impact potential, root cause and corrective actions. Strong verbal and written communication skills; excellent organizational and time utilization skills Ability to work independently and within project teams. Industry experience related to cGMP drug manufacturing, validation, and chemical process design Strong computer knowledge including Microsoft Office products
You will be responsible for performing commissioning and qualification of Pharmaceutical equipment, specifically systems for Oral Solid Dosage, Injectables, and Fill/Finish. This includes a variety of equipments such as RMG, CoMil, Tablet press, Coating Machine, blister packing machine, Vial Filling Line, PFS Line, Isolators (Negative & Positive), RABs (Open and Closed), GL Reactors, Dryer, Nutsche Filters, Centrifuges, Lyophilizers, etc. Your responsibilities will include developing CQMP, VMP, FRA, cGMP review sheet, interdependencies, System boundary, URS, SCA/SLIA, CLIA, DQR, SRA/QRA, SAT protocol, commissioning protocol, IQ protocol, OQ protocol, PQ protocol, process validation, and cleaning validation protocol. You will execute Commissioning, qualification, and validation activities for Pharma Process Equipments for API, Fill/Finish, and OSD. Additionally, you will review, analyze, and interpret system performance data, handle deviations/discrepancies, conduct investigations, CAPA, and ensure promotion of cGMP and regulatory compliance in assigned projects. Furthermore, you will exercise good judgment in selecting methods and techniques for obtaining solutions, maintain GDP, ALCOA practices, and have hands-on experience with Pharma Process Equipments. Drafting equipment operation SOPs will also be a part of your role. Qualifications & Other Requirements: - BS/MS in Engineering (Chemical, Pharma). - 4-10 years of experience in validation, quality systems, operations, engineering, or a combination thereof. - Experience in multiple GMP validation disciplines with advanced technical knowledge. - Knowledge of Validation Lifecycle approach, international regulatory requirements, and standards. - Experience with Documentum or Maximo is a plus. - Strong verbal and written communication skills, excellent organizational and time utilization skills. - Ability to work independently and within project teams. - Industry experience related to cGMP drug manufacturing, validation, and chemical process design. - Strong computer knowledge including Microsoft Office products.,
Position: CSV/Automation Engineer Responsibilities 5 to 10 years of experience in multinational pharma/biopharma companies with hands on experience in Process automation engineering Experience in designing and implementation/testing/commissioning/Qualification of (DCS/PLC/SCADA/BMS/EMS systems) Experience in trouble shooting for automation and control systems Drive and Lead Automation (DCS/PLC/SCADA/BMS) Projects Technical understanding and experience in of automation platforms, such as Delta V, Honeywell, Rockwell PLC, Siemens XFP Facilities, Utilities, and Equipment (FUE) qualification Unit operations automation qualification with Honeywell, Delta V, and PLC-based systems Computerized systems validation Support to change controls, investigations, deviations, and CAPAs Ability to effectively lead validation projects, coordinate contractors, junior level personnel and drive results Working closely with the systems integrators, automation leads & process leads Completing the FAT, SAT's, IQ, OQ. creating and executing the protocols & documentation Knowledge of E2500, V Model concepts along with GAMP5, S88, S95 Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for GMP regulated environments Must be able to solve routine problems with assistance. Strong organizational skills, excellent writing and communications skills Proficiency with Microsoft office including Word, Excel, and PowerPoint. Microsoft Project and Visio a plus Ability to travel up to 50% or more within and outside Malaysia Large scale project experience Valid Passport with no restrictions to travel Education Engineering degree in Automation, Instrumentation, EEE, ECE
As a Commissioning and Qualification Engineer for Pharmaceutical equipment, your role will involve working with a range of equipment including RMG, CoMil, Tablet press, Coating Machine, blister packing machine, Vial Filling Line, PFS Line, Isolators, RABs, GL Reactors, Dryer, Nutsche Filters, Centrifuges, Lyophilizers, etc. You will be responsible for developing various protocols such as CQMP, VMP, FRA, cGMP review sheet, URS, SCA/SLIA, CLIA, DQR, SRA/QRA, SAT protocol, commissioning protocol, IQ protocol, OQ protocol, PQ protocol, process validation, and cleaning validation protocol. In addition, you will execute Commissioning, qualification, and validation activities for Pharma Process Equipments for API, Fill/Finish, and OSD. Your role will also involve reviewing, analyzing, and interpreting system performance data, handling deviations/discrepancies, conducting investigations, CAPA, and ensuring cGMP and regulatory compliance. Your qualifications and other requirements for this role include: - BS/MS in Engineering (Chemical, Pharma). - 4-10 years of experience in validation, quality systems, operations, engineering, or a combination thereof. - Experience in multiple GMP validation disciplines with advanced technical knowledge. - Knowledge of Validation Lifecycle approach, international regulatory requirements, and standards. - Experience with Documentum or Maximo is a plus. - Strong verbal and written communication skills, excellent organizational and time utilization skills. - Ability to work independently and within project teams. - Industry experience related to cGMP drug manufacturing, validation, and chemical process design. - Strong computer knowledge including Microsoft Office products. Your role will also involve exercising good judgment in selecting methods and techniques for obtaining solutions, maintaining GDP, ALCOA practices, and drafting equipment operation SOPs.,
Position: Automation Engineer Position Summary Engineer with hands-on experience in Delta DCS systems, PI Historian to support the development and qualification of automation logic, Historian integrations in compliance with 21 CFR Part 11 and the latest validation standards. The role involves supporting design documents and developing qualification protocols, as well as configuring recipes, formulas, and controlling logic in Delta V DCS system, Historian systems along with Qualifications. Responsibilities Creation of DCS Recipe parameters, Formulas and developing process flows as per Tech transfer inputs. Review and interpret Software Design Specifications (SDS), Functional Specifications (FS), and related documents to understand automation requirements. Prepare comprehensive Qualification Documents including - Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) Ensure documentation aligns with 21 CFR Part 11, GAMP 5, and internal validation SOPs. Develop and configure DeltaV DCS logic, including Batch Recipes, Control Modules, Equipment Modules, Formulas and Phases. Maintain traceability matrices and ensure audit readiness of all documentation. Qualification of Historian systems. Qualifications & Other requirements Bachelor’s degree in Instrumentation, Automation, Electronics, or related engineering discipline. Minimum 4 years of experience in automation engineering within a regulated industry (pharma/biotech preferred). Strong working knowledge of DeltaV DCS systems. Expertise on 7016 – Delta Batch Implementation or equivalent hands-on experience. Understanding batch recipes, formulas, and control strategies. Solid understanding of 21 CFR Part 11, GAMP 5, and CSV principles. Strong documentation and technical writing skills. Familiarity with data integrity and audit trail requirements. Knowledge of ISA-88 batch control standards. Knowledge of ALCOA Principles. PI System Architecture Knowledge of PI Data Archive, Asset Framework (AF), Event Frames, and PI Vision. Interface Configuration Experience with OPC, Modbus, and other industrial protocols Data Modelling & Contextualization Building AF templates and event frames for batch and equipment tracking System Integration Connecting PI with MES, ERP & SCADA systems Reporting Tools Using PI Datalink, PI Vision, and PI Rt Reports for analytics and compliance reporting
The Commissioning & Qualification Engineer is responsible for providing engineering support to various areas, including process vessels, chromatography skid/column, lyophilizer, UF/DF skid, CIP, clean water skid, compressed gas distributions, solvent charging and handling systems, buffer preparation, glass washers and manufacturing support equipment. This engineer will be involved throughout the project lifecycle, including Factory Acceptance Testing (FAT), construction support, and Commissioning and Qualification (C&Q). Responsibilities Work on problems of diverse scope in which analysis of data requires evaluation of identifiable factors Perform several activities on clean water systems, compressed gases systems, CIP, mixing and storage vessels, distribution systems, and other pharmaceutical process equipment. Major activities include the following: Perform systems and P&ID Walkdowns Write and execute Factory Acceptance Tests (FATs), Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and cycle development protocols including development of final reports Commission and qualify equipment, and provide Equipment Turnover Packages (ETOPs) Provide process engineering support for clean water systems, compressed gases, CIP, and pharmaceutical process equipment Assist the project lead in the delivery and project management processes required to complete the project within timeline and budget. Promote cGMP and regulatory compliance into assigned projects Review and modification of standard operating procedures (SOPs) for various equipment Document, monitor, and report on project deliverables Manage project documentation such as protocols, reports, calibration certificates, and process trends and be able to report findings to clients and vendors Desired Skills And Experience BS degree or higher in chemical engineering or a related engineering or scientific discipline, or significant related experience Experience in construction safety and manufacturing safety Ability to work on complex or undefined problems and quickly identify and address critical issues Ability to create an environment of trust, compliance, continuous improvement and learning Demonstrated ability to manage multiple priorities with aggressive timelines Effective written communication utilizing GDP; effective oral communication skills; ability to write, type, express or exchange ideas; ability to convey information/instructions accurately Ability to relate with people at all levels within an organization, including diverse cultures Willingness to travel within the United States as needed Are you looking for a meaningful career that makes a difference in the world? Consider joining the Hyde Engineering + Consulting team where you will do just that. Hyde E+C contributes to helping people live longer, healthier lives by ensuring pharmaceutical and biopharmaceutical manufacturers can effectively and safely produce their life-enhancing and often life-saving medicines. To read more about Hyde's culture and benefits, visit our website: www.hyde-ec.com Hyde Engineering + Consulting is an equal opportunity, affirmative action employer.
This position shall perform site and office based engineering support, providing detailed design creation specifications creating and executing deliverables related to engineering projects. Responsibilities Support for the design of cGMP equipment, processes and utilities on pharma and biopharma projects. Create PFDs, P&IDs, GADs in AutoCAD for process equipment, clean and black utilities systems. Develop facility and equipment layouts, material/personnel flows, zoning and pressurization drawings Perform 3D modelling for process equipment and piping. Create Pipe Routing & Isometrics in AutoCAD. Support Pump Sizing, Pressure Drop & Line Sizing calculations. Preparation of Piping Material Specifications. Perform clash detection with supporting services. Prepare equipment lists, equipment data sheets, line lists, valve lists and BOQ. Proficient in preparing and reviewing P&IDs, PFDs, Layout and other System drawings for accuracy, completeness, and adherence to industry standards and project guidelines. Qualifications & Other Requirements BE degree in chemical or mechanical engineering 4-8 years’ experience in the Bio/pharmaceutical industry Familiar with design of facility, process equipment and utility systems (especially related to sanitary and sterile operations) Conducting site visits to inspect installed equipment and piping systems, ensuring proper installation and adherence to design specifications Developing and modifying technical drawings using AutoCAD, including 2D and 3D models. Collaborating with engineers, architects, and project managers to understand design needs and specifications. Strong understanding and practical experience with AutoCAD software Strong knowledge of piping codes and standards. Ensuring all designs adhere to relevant industry codes and standards(e.g., ASME, ANSI, DIN, EN, ISO, BS) and local regulations. Proficient in AutoCAD 2D Proficient in AutoCAD Plant 3D and Navisworks Knowledge of other 3D software such as Inventor, ProE, Solidworks, Revit is an added advantage Provide engineering expertise and drive technical decisions as active member. Strong verbal and written communication skills; excellent organizational and time utilization skills Ability to work independently and within project teams Strong computer knowledge including Microsoft Office products Organizing and maintaining an organized database of drawings and project files.
Position: Automation Engineer Position Summary Engineer with hands-on experience in Delta DCS systems, PI Historian to support the development and qualification of automation logic, Historian integrations in compliance with 21 CFR Part 11 and the latest validation standards. The role involves supporting design documents and developing qualification protocols, as well as configuring recipes, formulas, and controlling logic in Delta V DCS system, Historian systems along with Qualifications. Responsibilities Creation of DCS Recipe parameters, Formulas and developing process flows as per Tech transfer inputs. Review and interpret Software Design Specifications (SDS), Functional Specifications (FS), and related documents to understand automation requirements. Prepare comprehensive Qualification Documents including - Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) Ensure documentation aligns with 21 CFR Part 11, GAMP 5, and internal validation SOPs. Develop and configure DeltaV DCS logic, including Batch Recipes, Control Modules, Equipment Modules, Formulas and Phases. Maintain traceability matrices and ensure audit readiness of all documentation. Qualification of Historian systems. Qualifications & Other requirements Bachelor’s degree in Instrumentation, Automation, Electronics, or related engineering discipline. Minimum 4 years of experience in automation engineering within a regulated industry (pharma/biotech preferred). Strong working knowledge of DeltaV DCS systems. Expertise on 7016 – Delta Batch Implementation or equivalent hands-on experience. Understanding batch recipes, formulas, and control strategies. Solid understanding of 21 CFR Part 11, GAMP 5, and CSV principles. Strong documentation and technical writing skills. Familiarity with data integrity and audit trail requirements. Knowledge of ISA-88 batch control standards. Knowledge of ALCOA Principles. PI System Architecture Knowledge of PI Data Archive, Asset Framework (AF), Event Frames, and PI Vision. Interface Configuration Experience with OPC, Modbus, and other industrial protocols Data Modelling & Contextualization Building AF templates and event frames for batch and equipment tracking System Integration Connecting PI with MES, ERP & SCADA systems Reporting Tools Using PI Datalink, PI Vision, and PI Rt Reports for analytics and compliance reporting
This position shall perform site and office based engineering support, providing detailed design creation specifications creating and executing deliverables related to engineering projects. Responsibilities Support for the design of cGMP equipment, processes and utilities on pharma and biopharma projects. Create PFDs, P&IDs, GADs in AutoCAD for process equipment, clean and black utilities systems. Develop facility and equipment layouts, material/personnel flows, zoning and pressurization drawings Perform 3D modelling for process equipment and piping. Create Pipe Routing & Isometrics in AutoCAD. Support Pump Sizing, Pressure Drop & Line Sizing calculations. Preparation of Piping Material Specifications. Perform clash detection with supporting services. Prepare equipment lists, equipment data sheets, line lists, valve lists and BOQ. Proficient in preparing and reviewing P&IDs, PFDs, Layout and other System drawings for accuracy, completeness, and adherence to industry standards and project guidelines. Qualifications & Other Requirements BE degree in chemical or mechanical engineering 4-8 years’ experience in the Bio/pharmaceutical industry Familiar with design of facility, process equipment and utility systems (especially related to sanitary and sterile operations) Conducting site visits to inspect installed equipment and piping systems, ensuring proper installation and adherence to design specifications Developing and modifying technical drawings using AutoCAD, including 2D and 3D models. Collaborating with engineers, architects, and project managers to understand design needs and specifications. Strong understanding and practical experience with AutoCAD software Strong knowledge of piping codes and standards. Ensuring all designs adhere to relevant industry codes and standards(e.g., ASME, ANSI, DIN, EN, ISO, BS) and local regulations. Proficient in AutoCAD 2D Proficient in AutoCAD Plant 3D and Navisworks Knowledge of other 3D software such as Inventor, ProE, Solidworks, Revit is an added advantage Provide engineering expertise and drive technical decisions as active member. Strong verbal and written communication skills; excellent organizational and time utilization skills Ability to work independently and within project teams Strong computer knowledge including Microsoft Office products Organizing and maintaining an organized database of drawings and project files.