Lead PQ Engineer & PQ Engineer

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 aProject Quality Engineerto join the Borealis Project—a cutting-edge vector manufacturing facility supporting the production of modified viruses for cell and gene therapy. Thisclient-side roleplays a critical part in thelate stages of qualification, with a primary focus onPerformance Qualification (PQ)and quality activities leading into operational readiness. You will be responsible for ensuring the quality and compliance ofGrade C & D cleanroom environmentsandcritical utilities, such asWater 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 supportprotocol authoring, review, and executionfor PQs and related activities
• Ensurecleanroom and utility qualificationmeets 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 inpre- 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 withPQ-stage activities, especially cleanrooms and GMP utilities
• Solid knowledge of GMP, Annex 1, validation lifecycle, and risk-based approaches
• Experience inclient-sideroles with direct vendor/contractor interaction
• Strong documentation skills and attention to compliance detail
• Confident working in a cross-functional, high-paced project environment