Validation Engineer

Job summary

This temporary position focuses on advancing compliance and operational excellence as a Validation Engineer. The role involves preparing, executing, and finalizing validation protocols for new and modified equipment and processes within the facility.

Qualifications

• 3-5 years of validation/qualification experience, preferably with knowledge of cleaning validation.
• Proven experience in preparing and executing equipment and cleaning validation (VPP/VFR, IQ, OQ, PQ) in a GMP-regulated biotech/biopharma environment.
• Strong skills in deviation investigation, root cause analysis, and CAPA implementation.
• Solid understanding of regulatory requirements (e.g., FDA, EMA/EMEA, ICH, EU Annex 15, GAMP principles).
• Excellent cross-functional collaboration and communication skills.
• Proficiency in validation documentation, change control, and risk management.
• Ability to mentor junior team members.

Responsibilities

• Prepare, execute, and finalize validation protocols and reports, providing training and on-the-floor support.
• Investigate deviations and regulatory changes, driving root cause and CAPA with cross-functional partners.
• Lead cross-site validation improvements, ensuring consistency in documentation and execution.
• Perform final reviews of test data/reports for compliance with specifications and SOPs; manage change control impact assessments.

Education

• BS/MS in Engineering, Life Sciences, or related discipline preferred.

Skills

• Familiarity with digital validation tools, eQMS, and data systems.
• Demonstrated success in driving continuous improvement in validation lifecycle management.

Tools

• Proficiency with validation documentation and data review tools.