Commissioning Safety Lead

Commissioning Safety Lead

Manpower Engineering is hiring a Commissioning Safety Lead for a new construction project in Kalamazoo, MI. This is for one of our biopharmaceutical clients in the area working on commissioning of a new aseptic facility.



ROLE SUMMARY

This job description applies to the capital project to create a new aseptic facility on the client site in Kalamazoo, MI. This role will report to design and construction leads and is expected to be 12-18 months in duration.



ROLE RESPONSIBILITIES

• Review of technical specification documents for all civil, structural and architectural systems to be used as the basis for design


• Specific focus of architectural reviews is to ensure client quality, facility GMP, clean room finishes, and appearance standards are ensured.


• Oversee construction team and ensure installation requirements are met.


• Participate the execution of project work packages


• Review of Change notices for equipment and infrastructure.


• Construction and installation quality


• 3-D Model Review


• Participate in the Model Reviews with the engineering firm.


• Agree breakdown of facilities into model areas & schedule of completion of areas, to support construction schedule


• Review Clash detection reports & instigate Quality checks during design and construction phases of the project.


• Schedule - Support schedule development, management and tracking from Design through to final turnover to commercial operation. - duration is to 4QTR2022


• Participate in the development of Commission and Verification (C&V) activities on the project utilizing the client's Verification (ASTM E2500) model. Review and accept TOPs package, schedule training for plant personnel prior to turn over.


• Review of A/E firm engineering design deliverables


• Review of all relevant specs and data sheets for CSA systems particularly on modular clean room systems


• Review of vendor submittals and 3-D model development


• Identify project risks and opportunities and propose mitigation plans.


• Provide client review of contractor change notices


• Review of installation quality and workmanship


• Provide oversight, expertise and assistance to start-up efforts


• Assist in the resolution and tracking of field issues and Request for Information (RFIs)


• Track contractor progress and quality to contracted work package, design and site specifications.

QUALIFICATIONS:

Min qualification

• BS in Technical Field (engineering, building sciences, life science or equivalent).


• 10 years technical experience.

Essential requirements:

• Experience in safe work methodology and safe work approach - OSHA 10 minimum


• Direct experience within pharmaceutical manufacturing clean room facilities


• Knowledge and experience of project execution for GMP classified manufacturing / bio-containment facility design


• Experience of facility design in a 3D Model / BIM environment utilizing integrated project delivery


• Experience of vendor package management and design coordination


• Knowledge and experience of Bio-pharmaceutical commissioning & qualification an advantage.


• Good understanding of risk management methodologies, with a proven ability to apply in Bio-pharmaceutical operations.


• Strong knowledge of problem solving, root-cause analysis, operational excellence techniques.