Job Details

This job description applies to the capital project to create a new aseptic facility on the site in Kalamazoo, MI.
This role will report to design and construction leads.

Role responsibilities:

• Review of technical specification documents for all electrical and instrumentation systems to be used as the basis for design
• Specific focus of architectural reviews is to ensure quality, facility GMP, clean room finishes, and appearance standards are ensured.
• Participate the execution of project work packages
• Inspection plan & FAT / SAT schedule
• 3-D Model Review
• Assist in the resolution and tracking of field issues and Request for Information (RFIs)
• Review of installation quality and workmanship
• Provide client review of contractor change notices
• Support development of general procedures, metrics and deliverables required for successful delivery of the project objectives on time and within budget.
• Review of all relevant specs and data sheets for E&I systems
• Participate in the development of Commission and Verification (C&V) activities on the project utilizing Verification (ASTM E2500) model. Review and accept TOPs package, schedule training for plant personnel prior to turn over.
• Review Clash detection reports & instigate Quality checks during design and construction phases of the project.
• Participate in the Model Reviews with the engineering firm.
• Construction and installation quality
• Review of Change notices for equipment and infrastructure.
• Oversee construction team and ensure installation requirements are met.
• Agree breakdown of facilities into model areas & schedule of completion of areas, to support construction schedule
• Schedule – Support schedule development, management and tracking from Design through to final turnover to commercial operation. - duration is to 4QTR2022
• Review of A/E firm engineering design deliverables
• Review of vendor submittals and 3-D model development
• Identify project risks and opportunities and propose mitigation plans.
• Provide support and guidance to the construction team on E&I systems
• Provide oversight, expertise and assistance to start-up efforts
• Track contractor progress and quality to contracted work package, design and site specifications.

Qualifications:

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

Essential requirements:

• Good understanding of risk management methodologies, with a proven ability to apply in Bio-pharmaceutical operations.
• Experience of vendor package management and design coordination
• Knowledge and experience of project execution for MGP classified manufacturing / bio-containment facility design
• Experience in safe work methodology and safe work approach – OSHA 10 minimum
• Direct experience within pharmaceutical manufacturing clean room facilities
• Experience of facility design in a 3D Model / BIM environment utilizing integrated project delivery
• Knowledge and experience of Bio-pharmaceutical commissioning & qualification an advantage.
• Strong knowledge of problem solving, root-cause analysis, operational excellence techniques.

Physical/mental requirements:

• Can lift 75 Lbs. No physical limitations.
• Fluent in English, Spanish speaking beneficial.
• Valid driver’s license.

Non-Standard Work Schedule, Travel Or Environment Requirements:

• Possible to visit suppliers, fabricators, best practice meetings.
• Travel up to 10%.
• Successful candidate will be required to support design from A/E firm’s office and startup activities at Kalamazoo site.