02 Mar
Commissioning Safety Lead
Michigan, Kalamazoo , 49004 Kalamazoo USA

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 SUMMARYThis 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.


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