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 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