Engineer, C&q

Engineer, C&Q
Location - Singapore #LI Hybrid
About the Role:
The C&Q engineer is responsible to perform commissioning & qualification for CAPEX project and routine maintenance such as Requalification and Periodic Review to ensure facilities/equipment/systems are maintained in a validated state.
All C&Q activities are carried out in accordance to the global/site SOPs and the current version of GMP (Good Manufacturing Practice).
Key Responsibilities:

- Ensure commissioning and qualifications are in compliance with Quality Manual/Quality Modules/STDs/GOPs/site SOPs etc
- Perform gap assessment due to revision of GOP and Work procedures etc.
- Create & revise Site SOPs for commissioning & qualification
- Provide oversight as Engineering Compliance within Engineering department
- Engineering compliance oversight for approval of Equipment/Instrument Data Form & Spart parts material master change request form.
- Conduct regular compliance self-inspection within Engineering functions
- Conduct regular compliance walkdown with QA
- Oversight for Pre-audit preparation for Engineering
- Become Subject matter expert for relevant C&Q topics during regulatory/internal audits
- Support Audit Front/Back room during regulatory/internal audits
- Perform Annual Product Quality Review (APQR) for products.

**Commitment to Diversity & Inclusion**:

- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**

Essential Requirements:

- Possess knowledge & skills to use Kaye Validator AVS and Data Logger for Temperature Mapping.
- To support HVAC/Booths Requalification, Project Scope Identification.
- Perform Change Request Impact Assessment and identify all relevant C&Q deliverables
- Develop & track C&Q Deliverable List & schedule during CAPEX projects (e.g protocol generation, field execution, review and approval dates etc)
- Expedite and manage project vendors / contractors / 3rd parties / Managed Service providers (MSP), Perform new equipment FAT / SAT / inspections, Project Management, Project Cost Monitoring and Project Resource Planning
- Responsible to follow up closely with respective functions on items gating Commissioning & Qualification.
- Drafting of project documents (e.g Project Quality Plan, Master Qualification Plan, etc)
- Perform project reviews (e.g. Technical Quality Review (TQR), constructability, sustainability, HSE etc)
- Drafting of all required Commissioning & Qualification Deliverables (e.g URS, GMP-FRA, Concept Paper, Qualification Plan, Commissioning Test Plan, CTS, Design Qualification, TSIQ, TSOQ, TSPQ, CIP, SIP, Sterile Hold Studies, Qualification Release documents, Qualification Summary Reports etc etc)

Desirable Requirements:

- Perform Pre-Requisite checks for each Commissioning & Qualification Phases prior to protocol execution
- Management of project deficiencies, project deviations, Non-conformance Report (NCR), 1QEM (Deviation) 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 post field execution
- Ensure all commissioning & qualification protocols are timely reviewed and QA post approved before due date
- Support routine maintenance of the validated system status (e.g Requalification, Periodic Review, Ad-hoc change request qualification etc)


**Division**

Operations

**Business Unit**

LARGE MOLECULES

**Country**

Singapore

**Work Location**

Singapore

**Company/Legal Entity**

NOV SINGAPORE PHARMA MANUFG

**Functional Area**

Technical Operations

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No