Senior Validation Engineer

We are currently supporting a global biologics manufacturer that is in active CQV execution at its newly built drug substance manufacturing facility in the Research Triangle Area of NC. The CQV team is deep in late stage execution with system turnover underway and PPQ preparation actively in progress.

This role is focused on hands on execution of SIP validation activities within a fast paced, cross functional GMP environment. It is well suited for a contract validation engineer with solid experience in SIP cycle development and performance qualification who has worked within Kneat or Kneat Gx as their electronic validation management platform.

Responsibilities

• Execute IQ, OQ, and PQ protocols across stainless steel manufacturing systems with a primary focus on SIP cycle development, performance qualification, and system turnover in a cGMP biologics environment
• Write, review, and execute validation documentation within Kneat Gx, ensuring full traceability from requirements through protocol execution and approval
• Support system turnover activities and prepare qualified systems for handoff into GMP operations ahead of PPQ
• Work cross functionally with engineering, quality, automation, and operations teams on a daily basis in an active construction and qualification environment
• Identify and resolve deviations and discrepancies during protocol execution and support documentation and closure
• Contribute to protocol standardization and CQV best practices as the site scales into full operations and expansion activities begin

Requirements

• 5-8+ years of hands on CQV or Validation Engineering experience in a GMP biopharmaceutical or sterile drug substance manufacturing environment
• Direct SIP experience required including cycle development and PQ execution in a stainless steel GMP setting
• Proficiency in Kneat or Kneat Gx required
• Strong working knowledge of IQ, OQ, PQ protocols and cGMP documentation standards
• Experience with clean utilities, CIP systems, bioreactors, WFI, or upstream biologics systems strongly preferred
• Ability to work onsite full time on site if needed

***NO 3RD PARTY VENDORS***