Process C&Q Engineer

Leap29; Stockholms län; Sur place; SEK 994 073 - 1 391 702; Plein temps

Résumé du poste

Leap29 is seeking an experienced Process C&Q Engineer for a freelance role in Sweden, aimed at supporting a high-profile pharmaceutical project. This position involves executing critical commissioning activities, focusing on compliance with GMP standards.

The ideal candidate will have 5–10+ years of relevant experience in the pharmaceutical sector, with strong hands-on knowledge of OQ and PQ processes. This is an excellent opportunity for a skilled professional seeking to make a significant impact on a pivotal project.

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.

Responsabilités

• Execute commissioning activities following the completion of IQ.
• Lead and support OQ and PQ for process equipment and systems.
• Perform hands-on testing and operational verification.

Connaissances

Process Commissioning & Qualification

Hands-on OQ and PQ execution

GMP Compliance

Troubleshooting

Description du poste

Job Advertisement: Process C&Q Engineer – Location: Sweden – Contract: Freelance – 3 months initial, then 6-month 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). It 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 walk‑downs, 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.