Quality Engineer, Validation Manager

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:

• Lead and manage the Validation and Quality Engineering teams responsible for qualification and validation activities across facilities, utilities, equipment, and processes.
• Oversee all commissioning, qualification, and validation (CQV) activities, including URS development, IQ, OQ, PQ, engineering studies, risk assessments, and summary reporting.
• Develop and maintain the site Validation Master Plan (VMP), ensuring alignment with current regulatory guidance and industry best practices.
• Provide technical support and subject matter expertise during regulatory inspections, client audits, and internal quality reviews.

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.