Job Title: Project Quality Engineer & Lead PQ Engineer Project: Borealis – Vector Manufacturing Facility
Location: Onsite, Client-Side
Contract Type: Contract / Full-Time
Overview
We are seeking a Project Quality Engineer to join the Borealis Project—a cutting-edge vector manufacturing facility supporting the production of modified viruses for cell and gene therapy. This client-side role plays a critical part in the late stages of qualification, with a primary focus on Performance Qualification (PQ) and quality activities leading into operational readiness. You will be responsible for ensuring the quality and compliance of Grade C & D cleanroom environments and critical utilities, such as Water for Injection (WFI). The role demands strong expertise in protocol authoring, execution oversight, and alignment with GMP, Annex 1, and ISO 14644 standards. This is an ideal opportunity for a quality professional who thrives in fast-paced project environments and is confident taking ownership of PQ and post-PQ responsibilities as the facility moves toward regulatory readiness.
Key Responsibilities
Lead or support protocol authoring, review, and execution for PQs and related activities
Ensure cleanroom and utility qualification meets GMP, Annex 1, and ISO 14644 expectations
Track and close out open items from FAT/SAT through to PQ stage and onwards
Interface with stakeholders to ensure alignment across validation, QA, and engineering
Review and approve quality documentation for PQ and post-PQ readiness
Monitor ongoing compliance, deviations, and change control linked to final qualification stages
Participate in pre- and post-PQ reviews, walkdowns, and readiness assessments
Support final documentation packages for inspection and handover
Requirements
~5+ years in pharmaceutical quality or validation roles
~ In-depth experience with PQ-stage activities, especially cleanrooms and GMP utilities
~ Solid knowledge of GMP, Annex 1, validation lifecycle, and risk-based approaches
~ Experience in client-side roles with direct vendor/contractor interaction
~ Strong documentation skills and attention to compliance detail
~ Confident working in a cross-functional, high-paced project environment