Top 3 must have's: Life science Domain, Validation Skills, Delta V & MES Validation
Job Summary:
The Senior Validation Engineer will lead and execute commissioning and qualification (C&Q) activities for automation systems at the. 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.
________________________________________
Key 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. [Cognizant...-June-2025 | PDF]
________________________________________
Required Qualifications:
• 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.
________________________________________
Preferred Qualifications:
• 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.