Commissioning Safety Lead

Commissioning Safety Lead

02 Mar 2021
Michigan, Kalamazoo, 49004 Kalamazoo USA

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.


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.


  • 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.


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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Job Details

  • ID
  • State
  • City
  • Job type
  • Salary
    USD $60 - $70 per hour 60 - 70 per hour
  • Hiring Company
    Manpower Engineering
  • Date
  • Deadline
  • Category

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