Process Commissioning & Qualification (C&Q) Engineer @ Sweden -Storgatan at Advanced Manufacturing Tech Solutions (AMTSOL)

Sveg, Jämtland County, Sweden -

Full Time

Start Date

Immediate

Expiry Date

26 Apr, 26

Salary

0.0

Posted On

26 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Process Commissioning, Qualification, Operational Qualification, Performance Qualification, GMP Compliance, GAMP 5, Deviation Handling, Troubleshooting, Manufacturing Support, Engineering Collaboration, Testing, Data Integrity, Regulatory Inspection, Hands-on Experience, Plant Operations, Process Expertise

Industry

Pharmaceutical Manufacturing

Description

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.

Responsibilities

The role involves executing Operational Qualification (OQ) and Performance Qualification (PQ) activities for process equipment and systems, as well as supporting process and equipment commissioning. Candidates will work closely with various teams to ensure compliance and readiness for regulatory inspections.