Commissioning Safety Lead



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Branch Information

Michigan Engineering - (USA) 2851 Charlevoix Drive Southeast Suite 323 MI Grand Rapids , MI 49546



Job Description

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.