Validation Engineer

1 month ago


india IPS-Integrated Project Services Full time

Looking for a candidate with Good Knowledge in Bio-Pharmaceutical manufacturing Processes and the Process equipment for OSD/Sterile/Creams/Ointment manufacturing, API manufacturing/High Potent compound manufacturing (Product/Personnel/facility Containment requirement) and facility design requirement.

Should be able to conduct Quality Audits, Gap Analysis of bio-pharmaceutical manufacturing facilities to ensure international regulatory compliance.

Should have Sound knowledge about international regulatory guidelines for Biopharmaceutical manufacturing (cGMP, Schedule M, FDA, WHO, EMEA, EU, TGA, PICs, ICH & ISPE, ASME, ISS codes, ASHRAE


Job Description

  • Prepare Validation/Verification master plan for Bio-pharmaceutical facility
  • Develop project schedule for Commissioning/validation (Facility, process equipment, Utility system)
  • Track the project schedule
  • Conduct Quality Risk assessment
  • Conduct Impact assessment for process equipment/utility system
  • Provide templates for Qualification documents
  • Write, guide and execute validation protocols/templates, such as Installation, Operational, and Performance Qualifications (IOPQs) for process equipment (OSD, Injectable, API facility), Guidance on qualification protocol preparation for HVAC system, Clean Utilities, and Cleaning Validations (CVs).
  • Plan, manage, and execute the start-up, commissioning, and validation of new equipment, Utility systems and facility qualification
  • Participate in Factory Inspection for Process equipment, utility system (PUW, WFI, HVAC, BMS, SCADA),
  • Assist in the creation of cleaning and process validation master plan,
  • Identify and define project and process improvement opportunities
  • Develop C&Q project schedule
  • Track project schedule
  • Follow Biotech/Pharmaceutical industry standards in generating and updating supporting documentation such as P&IDs, material and equipment specifications / datasheets, and user requirement specifications
  • Quality deliverables by strong interaction with inhouse team, clients & vendors

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