Process Commissioning & Qualification Engineer @ Sweden -Storgatan

Role Overview

We are seeking experienced Process C&Q Engineers / Commissioning Experts to support late-stage commissioning and qualification activities in a GMP-regulated pharmaceutical manufacturing facility in Sweden.

The role is heavily focused on transitioning from completed IQ into execution of OQ and PQ, requiring hands-on process, plant, and operations experience. Candidates must be comfortable working directly on the shop floor with manufacturing, engineering, and quality teams.

Key Responsibilities

Commissioning & Qualification Execution

• Support process and equipment commissioning following completion of IQ.

• Lead and execute Operational Qualification (OQ) and Performance Qualification (PQ) activities for process equipment and systems.

• Perform hands-on testing, challenge tests, and operational verification aligned with approved protocols.

• Support system walkdowns, readiness checks, and turnover from Engineering to Quality.

Process & Plant Support

• Work closely with Manufacturing, Engineering, Automation, and QA during OQ/PQ execution.

• Provide process expertise during execution, deviation handling, and troubleshooting.

• Support start-up, trial runs, and performance runs during PQ.

• Ensure equipment and processes are operated as per intended use and validated state.

GMP Documentation & Compliance

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

• Support deviation investigations, CAPAs, and impact assessments related to OQ/PQ.

• Contribute to final qualification reports and readiness for regulatory inspection.

• Ensure data integrity, traceability, and right-first-time execution.

Required Experience & Qualifications

Mandatory

• 5–10+ years of experience in Process Commissioning & Qualification within pharma or biopharma manufacturing.

• Strong hands-on experience executing OQ and PQ (not only documentation).

• Solid process / plant experience (e.g., upstream, downstream, formulation, fill-finish, utilities, or packaging).

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

• Good understanding of GMP, GAMP 5, and validation lifecycle.