Sr. Validation Engineer

Job Title

Summary: Top 3 must have's: Life science Domain, Validation Skills, Delta V & MES Validation

Roles And Responsibilities

• 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.

Education And Experience

• 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.