Job Description

Job Advertisement: Process C&Q Engineer

Location: Sweden
Contract: Freelance – 3 months initial, then 6-month extension
Extension: Strong potential to extend further

Overview

We are seeking an experienced Process C&Q Engineer to join a GMP pharmaceutical manufacturing site in Sweden, currently in the late stages of commissioning. This role is critical in supporting the transition from Installation Qualification (IQ) into Operational Qualification (OQ) and Performance Qualification (PQ).

This is a hands-on, execution-focused position, ideal for professionals with extensive on-site commissioning and qualification experience. You will work closely with Manufacturing, Engineering, Automation, and Quality teams to ensure seamless execution and compliance with GMP standards.

Key Responsibilities

• Execute commissioning activities following the completion of IQ.


• Lead and support OQ and PQ for process equipment and systems.


• Perform hands-on testing, challenge testing, and operational verification.


• Support system walkdowns, readiness checks, and engineering handover.


• Collaborate with Manufacturing, Engineering, Automation, and QA teams during execution.


• Assist with start-up, trial runs, and performance runs.


• Address deviations, conduct investigations, and troubleshoot issues during OQ/PQ.


• Execute qualification activities in compliance with GMP, GAMP 5, and site SOPs.


• Contribute to final qualification reports and ensure inspection readiness.

Qualifications

• 5–10+ years of experience in Process Commissioning & Qualification within the pharmaceutical or biopharmaceutical industry.


• Proven hands-on experience in OQ and PQ execution.


• Strong background in process or plant operations (e.g., upstream, downstream, formulation, fill-finish, utilities, packaging).


• Demonstrated experience working on-site in live GMP manufacturing environments.


• Solid understanding of GMP, GAMP 5, and the validation lifecycle.

This is an excellent opportunity for a skilled Process C&Q Engineer to contribute to a high-profile pharmaceutical project. If you are a motivated professional with a strong background in commissioning and qualification, we encourage you to apply.

Note: This is a freelance position with an initial 3-month contract and a strong potential for further extensions.

Location: Sweden
Contract Type: Freelance
Duration: 3 months initial, with potential for a 6-month extension and beyond.