The C&Q Engineer is responsible for Commissioning & Qualification (C&Q) of equipment/system. All C&Q activities are carried out according to site SOPs and the current version of GMP (Good Manufacturing Practice).
The responsibilities of the C&Q Engineer include:
• Ensure 95% training completion at all times
• Already possess knowledge & skills to use Kaye Validator AVS and Data Logger for Temperature Mapping
• Drafting of all required Commissioning & Qualification Deliverables (e.g GMP-FRA, Concept Paper, Qualification Plan, Commissioning Test Plan, CTS, Design Qualification, TSIQ, TSOQ, TSPQ, CIP, SIP, Qualification Release documents, Qualification Summary Reports etc)
• Attend project meetings
• Stakeholder Management & Alignment with QA, MU, MS&T, Projects etc
• Develop & Track the Overall C&Q schedule (e.g protocol generation, field execution, review and approval dates etc)
• Responsible for following up closely with respective functions on items gating Commissioning & Qualification.
• Perform Pre-Requisite checks for each Commissioning & Qualification Phases prior to protocol execution
• Management of project deficiencies, project deviations, Non-conformance Report (NCR), 1QEM (Trackwise) etc and lead investigation (e.g root cause analysis) during commissioning & qualification
• Perform field execution of all required Commissioning & Qualification Deliverables (e.g CTS, TSIQ, TSOQ, TSPQ, CIP, SIP, Sterile Hold Studies etc etc)
• Perform commissioning & qualification protocol compilations
• Ensure all commissioning & qualification protocols are reviewed and QA post approved before due date
• Perform provisional and final project handover
• Develop project document management and archiving concept
• Develop & execute Sterile Hold Studies for MU equipment
Any other tasks as assigned by C&Q Leader.
Job Requirement:
· Degree in engineering (Dipl. Ing. / M. Sc. / B. Sc.) or equivalent·
· More than 1 year of engineering project / commissioning / qualification / Compliance in Pharma
· Good technical knowledge with demonstrated ability to deliver safe, effective and fully compliant projects
· Outstanding GxP and regulatory knowledge
· Advanced HSE knowledge
· Fluent in English and proficient in local language
