QA Commissioning Engineer

**Responsibilities**:
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We are seeking for a QA Commissioning Engineer to support our client for the duration of 6 months period. Responsibilities: Assist in developing and implementing Corporate and Site SOPs, and Inspection Forms. Attend Commissioning activities for Project to ensure the execution is following GMP regulations, and specification requirements while meeting client standards. Work as part of a multidiscipline team to support the design, construction, commissioning and qualification of new and modified life science facilities, equipment, and processes. Assist to define/reviewing the Commissioning/Qualification/Validation boundaries and developing the facility system list & boundary. Attend and conducts the Commissioning/Qualification/Validation functions for systems including but not limited to Utilities, Equipment, Facility, Cleaning, Automation, and/or Process Qualification as well as the preparation and review of User Requirement Specification, Validation Master Plan, Protocols (IQ, OQ, PQ), and procedures Attends and/or witnesses construction reports/testpacks, FAT, SAT and commissioning plans/ records /protocols/ testing activities to support Commissioning/Qualification/Validation. Assist in planning and coordinating walkdowns between Construction(Main Contractor, Subcons/Vendors), Commissioning and Client. Ensure planning, preparation, review and execution of the system walkdown in compliance of approval procedures and approval & issuance of Mechanical Completion Certificate. Responsible for monitoring and coordinating the handover of a mechanically complete facility from Construction to Commissioning to Client. Identifies & communicates priority systems to drive commissioning activities. Liaises between Construction and Systems Completion to maintain system prioritization. Provides key interface with Commissioning team to ensure that commissioning checksheets are accurately completed and are submitted in a timely manner to meet handover dates - expedites when required monitors system status. Coordinates with Subcontractor to ensure efficient and safe execution of MC and turnover. Interfaces with Planning and Construction to assist in meeting scheduled MC dates. Ensures that Construction is working on prioritized area completion so that transition from area to system MC meets agreed project schedule/handover dates. Reports MC and commissioning progress to the QA/Commissioning Manager/Project Manager. Sets up, manages and reports System Completion metrics (i.e. MC and commissioning checksheet progress, plan vs. actual system handovers, outstanding punchlist items, etc.) Coordinate and lead contractor with arrangement of MC walkdowns / punchlist development and ensures the Contractor rectifies A punchlist items in a timely/orderly fashion to meet scheduled turnover dates. Ensures final-approved system punchlists are input into the CMS database. Ensures Commissioning Completion certificates are prepared, signed by appropriate supervisors/managers and distributed as stipulated in project coordination procedures. Coordinates preparation and review of Vendor Documents (VDR) and Handover Dossier format and helps set up all dossiers and subsequently for clients review and approval. Verifies all review and sign-offs of Handover Dossiers and coordinates handover to Start Up team/ C&Q and client. Requirements: Bachelor's Degree, Post Graduate Diploma, Engineering (Chemical/Mechanical), Science & Technology or equivalent Minimum 2 years working experience in Engineering, Construction and Manufacturing Industry preferably in high technology and pharmaceutical projects Working knowledge in PIC/S, cGMP, GEP, GDP and FDA Regulations Familiar with Construction Site Environment Must be comfortable with contract basis roleBenefits