Sr. Validation Engineer

Summary

The Senior Validation Engineer will lead and execute commissioning and qualification (C&Q) activities for automation systems. This role ensures compliance with GMP regulations and internal quality standards, supporting the successful delivery of validation documentation and execution for new and existing systems.

• Lead and manage C&Q lifecycle activities including URS, DQ, IQ, OQ, and PQ for automation and process systems.
• Collaborate with cross‑functional teams including engineering, QA, manufacturing, and automation to ensure validation deliverables align with project timelines.
• Develop and review validation protocols, reports, and supporting documentation in compliance with FDA, EU standards.
• Utilize tools such as Kneat, GVault, or equivalent systems for document control and validation tracking.
• Provide technical guidance and mentorship to junior validation engineers and contractors.
• Support change control processes and deviation investigations related to validated systems.
• Participate in audits and inspections, providing subject‑matter expertise on validation practices and documentation.
• Ensure alignment with the overall execution and resource plan as outlined in the C&Q strategy.

Cognizant...

-June-2025 | PDF

• Bachelor's or Master's degree in Engineering, Life Sciences, or related field.
• Minimum 7+ years of experience in validation within the pharmaceutical or biotech industry.
• Strong knowledge of cGMP, FDA, ICH, and EU regulations.
• Proven experience with commissioning and qualification of automation systems.
• Proficiency in validation tools such as Kneat, GVault, or similar platforms.
• Excellent communication, documentation, and project coordination skills.
• Experience working on large‑scale C&Q projects in a regulated environment.
• Familiarity with systems and validation practices is a plus.
• PMP or equivalent project management certification.

Mid‑Senior level

Contract

Pharmaceutical Manufacturing