GxP Validation Engineer

One of our large clients in the pharmaceutical industry in Spring House, PA is seeking a highly skilled and detail-oriented GxP Validation Engineer to support validation activities for CAR T-cell therapy manufacturing equipment and systems. This role is critical to ensuring compliance with GMP standards and regulatory requirements across a range of manufacturing and laboratory technologies.

Key Responsibilities:
• Execute GxP validation activities for CAR T manufacturing equipment, including specialized systems and cell processing instruments, such as Prodigy.
• Develop and author validation documentation including protocols, connection diagrams, and final reports.
• Validate temperature control units such as refrigerators and freezers.
• Collaborate with cross-functional teams to ensure validation deliverables meet project timelines and regulatory standards.
• Support audits and inspections by providing validation documentation and subject matter expertise.

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• Minimum 3-5 years of experience in GxP validation within a GMP-regulated environment.
• Strong understanding of GMP compliance and validation lifecycle.
• Familiarity with temperature-controlled equipment validation.

• Knowledge of automation systems and Computer System Validation (CSV).
• Proven experience with CAR T manufacturing equipment.
• Hands-on experience with MeS and DCS validation.

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.