Senior Validation Engineer

We are seeking a Process Validation Engineer with 4–6 years of experience in the pharmaceutical or biotechnology industry. The ideal candidate will be responsible for executing and supporting process validation activities to ensure manufacturing processes consistently produce products that meet predetermined quality attributes in compliance with cGMP and regulatory requirements.

• Develop, review, and execute Process Validation protocols and reports (IQ, OQ, PQ / PPQ) for pharmaceutical manufacturing processes.
• Support process performance qualification (PPQ) activities for new and existing products.
• Collaborate with Manufacturing, Quality Assurance, and Engineering teams to ensure validated processes meet regulatory and operational requirements.
• Conduct risk assessments (FMEA / Risk Analysis) for manufacturing processes and validation strategies.
• Analyze process data and prepare statistical summaries and validation reports.
• Support technology transfer activities and ensure validation requirements are met during process scale‑up.
• Investigate deviations, CAPA, and non‑conformances related to validation activities.
• Ensure all validation documentation complies with cGMP, FDA, and global regulatory guidelines.
• Participate in change control processes related to manufacturing processes and validation impact assessments.
• Provide technical support during internal and regulatory audits.

• Bachelor’s or Master’s degree in Engineering, Pharmaceutical Sciences, Biotechnology, Chemical Engineering, or related field.
• 4–6 years of experience in process validation within the pharmaceutical, biotech, or life sciences industry.
• Hands‑on experience with Process Validation lifecycle (Stage 1 – Process Design, Stage 2 – Process Qualification, Stage 3 – Continued Process Verification).
• Strong understanding of cGMP regulations, FDA guidelines, and validation principles.
• Experience working in sterile manufacturing, biologics, or drug product manufacturing environments is preferred.
• Knowledge of statistical tools, process capability analysis, and validation data analysis.
• Experience with deviation investigations, CAPA, and change control systems.
• Strong documentation, analytical, and cross‑functional collaboration skills.

• Experience with biologics, aseptic processing, fill‑finish, or vaccine manufacturing.
• Familiarity with regulatory submissions and inspection readiness.
• Knowledge of quality systems such as Track Wise, Veeva, or similar systems.