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CQ Engineer

2 months ago

Singapore PROJECT DELIVERY PARTNERS PTE. LTD. Full time
Roles & Responsibilities

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


Tell employers what skills you have

Document Management
GxP
Archiving
Hardware
GMP
Investigation
Root Cause Analysis
Electrical
Protocol
Stakeholder Management
Manufacturing
Linux
Commissioning
Trackwise
Mapping