QA - Validation Engineer (Pharma Background)

7 days ago

Vadodara, India B&S Group Full time
  • Lead the qualification of pharmaceutical manufacturing equipment including filling, packaging, HVAC, and utility systems.
  • Prepare IQ/OQ/PQ protocols and associated reports for new equipment installations, modifications, and periodic revalidations.
  • Prepare Validation summary report.
  • Develop and maintain validation plans, risk assessments (e.g., FMEA), and equipment qualification documentation as per ICH Q9.
  • Ensure equipment complies with applicable regulatory requirements and internal validation policies.
  • Collaborate with cross-functional teams such as Engineering, Production, Quality Assurance, and Maintenance to coordinate validation activities.
  • Review vendor documentation (FAT/SAT reports, manuals, drawings) for validation impact and integration into qualification packages.
  • Troubleshoot validation and equipment issues, lead investigations for equipment-related deviations and out-of-spec results (OOS).
  • Maintain validation lifecycle documentation including periodic reviews, change control impact assessments, and equipment decommissioning plans.
  • Act as a Subject Matter Expert (SME) for equipment qualification.
  • Train and mentor other validation team member.
  • Understanding of pharmaceutical quality management system (Change control, deviation).

Required Qualifications:

  • Bachelor's degree in Pharmaceutical, Mechanical Engineering, Chemical Engineering, Industrial Engineering, or related technical discipline.
  • 5 years of experience in equipment validation in a GMP-regulated pharmaceutical manufacturing environment.
  • In-depth knowledge of GMP, EU GMP Annex 15 and ISPE guideline.
  • Proven experience validating a wide range of process and packaging equipment (e.g., Filling machines, capping machines, labelling machines, Load cells, facility, and utilities etc.).
  • Strong understanding of automation and control systems and their integration into validation processes.
  • Excellent technical writing, documentation, and project management skills.

Preferred Skills:

  • Experience in non-sterile oral liquids manufacturing equipment.
  • Familiarity with CSV principles for automated equipment and PLC/SCADA systems.
  • Knowledge of data integrity principles and ALCOA+ compliance.
  • Proficiency with quality management systems (e.g., Master Control, Track Wise).
  • Six Sigma, Lean Manufacturing, or validation certification (e.g. ISPE) is a plus.

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