Quality Engineer, Validation Supervisor

I'm currently working with an established Pharma company that has been keen on innovation for the last 50 years. Despite having the first FDA approved injection of its kind, growth is still the name of the game. It's time to continue to build out their Quality leadership team.

Responsibilities:

• Supervise and coordinate day-to-day validation and qualification activities, including commissioning, IQ, OQ, and PQ, ensuring timely and compliant execution.
• Ensure all validation documentation meets internal and regulatory expectations for accuracy, completeness, and traceability, with strict adherence to data integrity principles (ALCOA+).
• Prepare and review validation protocols, risk assessments, test plans, summary reports, and change control documentation, supporting robust and compliant validation practices.
• Participate in internal and external audits, serving as the subject matter expert (SME) for validation data and documentation.

The ideal candidate brings:

• A strong technical foundation in validation and aseptic processing
• Deep understanding of regulatory compliance
• Proven leadership and project management capabilities
• Experience with isolators and RABS (highly preferred)

Competitive comp package:

• Bonus
• Health, vision, dental insurance

This position involves close collaboration with cross-functional teams in Manufacturing, Engineering, and Quality to ensure validation activities are executed efficiently, documented thoroughly, and maintained in a state of compliance. This position plays a key role in ensuring that facilities, utilities, equipment, and processes operate in compliance with cGMP and regulatory expectations.