Process Commissioning & Qualification (C&Q) 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 .