Lead Process Engineer (Pharmaceutical / Biotech)

Lead Process Engineer (Pharmaceutical / Biotech)

We are currently sourcing an experienced Process Engineer to lead technical design and validation for a new pharmaceutical manufacturing facility build.

This contract role offers a compelling dual-scope: executing core process engineering (IQ/OQ/PQ, process flow optimization) while simultaneously operating as the GE Process Lead. You will be tasked with translating business requirements into precise technical scopes, coordinating cross-functional facility layouts, and managing engineering partners/EPCMs to deliver critical design packages.

Key Requirements:

• Proven background in Pharma/Biotech manufacturing environments.
• Hands-on expertise authoring technical documentation (URS, PFDs, P&IDs).
• Comprehensive knowledge of FDA, GMP, and ICH regulatory standards.
• Experience managing external engineering consultants.
• Clean utility system design experience (e.g., Purified Water, Process Nitrogen) is highly desirable.

If you possess the required technical depth and vendor management capabilities to drive this facility build from the ground up, please reach out directly or submit your resume for review.