Validation Engineer

 

 

 

Led end-to-end CQV and CSV lifecycle activities, including URS, risk assessments, IQ/OQ/PQ execution, and final reporting for GMP-regulated environments.

Executed risk-based validation strategies compliant with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.

Managed Commissioning of Plant Utilities, Commissioning and qualification of clean utilities, process equipment, HVAC systems, Automation and computerized systems for Biotech API and Fill Finish facilities.

Experienced in commissioning, qualification, and validation of Water Systems (PW/WFI), CIP/SIP systems, autoclaves, bioreactors, nitrogen and process air systems.

Demonstrated knowledge of upstream and downstream manufacturing equipment qualification, supporting GMP-compliant project execution throughout the equipment and utility lifecycle.

Developed and reviewed validation documentation including VMPs, SOPs, RTMs, protocols, and summary reports.

Performed FAT, SAT, commissioning, and shakedown testing ensuring seamless transition into qualification phases.

Utilized platforms like Kneat / Veeva / TrackWise for electronic validation lifecycle management.

Conducted GxP impact assessments, data integrity risk assessments, and FMEA analyses to define validation scope.

Collaborated cross-functionally with QA, Engineering, IT, and Vendors to deliver projects on schedule.

Managed deviations, CAPA, and change controls ensuring audit-ready documentation at all stages.

Mentored junior engineers on CQV/CSV best practices and regulatory expectations.

            1. Deviation handling
            2. IQ/OQ/PQ execution
            3. Audit findings and responses

Knowledge on Regulatory frameworks (FDA, ICH, EU, MHRA, GAMP 5, ISPE,  ASME BPE)

 

A bachelor’s degree or master’s degree in chemical engineering, Biotech Engineering, Mechanical Engineering, Chemistry or Life Sciences, in the Pharmaceutical/Life Sciences industry. Engineering Consultancy (for Biopharma).

 

Core Focus Areas:

Commissioning, Qualification & Validation (CQV)

Regulatory compliance (FDA, ICH, GAMP 5)

Commissioning of Plant Utilities and Integration and Handshake with other systems, Clean Utilities, HVAC (CIP, SIP, WFI system, Part Washer and HVAC system and manufacturing process equip)

Equipment & system qualification (HVAC, Clean Utilities, manufacturing Process systems)

Documentation, execution, and lifecycle validation

Key Responsibilities:

Develop and execute CQV/CSV validation strategies

Prepare and review IQ, OQ, PQ protocols and reports

Perform risk assessments (FMEA, GxP, data integrity)

Support design reviews, FAT/SAT, commissioning activities

Collaborate with Project, QA, Engineering, Manufacturing, IT, System Vendors

Maintain audit-ready documentation

Use tools like Kneat, Veeva, TrackWise

Ensure compliance with: 

          1. FDA 21 CFR Part 11
          2. EU Annex 11
          3. ICH Q8/Q9/Q10
          4. GAMP 5
          5. ISPE Guideline

Lead/mentor junior team members

Manage timelines, stakeholders, and project execution