Job Title: Validation Engineer

Key Responsibilities:

• Develop, review, and execute validation protocols (IQ/OQ/PQ) for equipment, utilities, facilities, and processes.
• Prepare and maintain comprehensive validation documentation, including validation master plans, risk assessments, and final reports.
• Lead and support the qualification of manufacturing equipment (e.g., autoclaves, HVAC, cleanrooms, CIP/SIP systems).
• Conduct cleaning, process, and computer system validations according to site procedures and regulatory guidelines.
• Investigate and resolve validation deviations; ensure root cause analysis and CAPA implementation.
• Collaborate with cross-functional teams including QA, QC, Manufacturing, and Engineering.
• Participate in audits and inspections (FDA, MHRA, internal) by presenting validation documentation and addressing related queries.
• Stay up-to-date with current industry practices and regulatory expectations.

Required Qualifications:

• Bachelor’s or Master’s degree in Engineering, Pharmaceutical Sciences, or a related technical discipline.
• Minimum 6 years of hands-on validation experience in a cGMP-compliant pharmaceutical or biotech environment.
• In-depth knowledge of FDA, EU, ICH, and other applicable validation guidelines.
• Experience with cleaning validation, process validation, equipment qualification, and facility/utilities qualification.
• Proficient in writing validation protocols and technical reports.
• Strong analytical, documentation, and communication skills.

Preferred Qualifications:

• Experience with CSV (Computer System Validation) and 21 CFR Part 11 compliance.
• Familiarity with Quality Risk Management (QRM) tools such as FMEA.
• Six Sigma or Lean certification is a plus.
• Experience in sterile manufacturing or fill-finish operations.