Great client is looking for a C/S/A Lead for a 12-18 month contract assignment. This is in support of a capital project to create a new aspectic facility. This report to both the design and construction leads. Must have specific pharmaceutical manufacturing experience.
location: Kalamazoo, Michigan
job type: Contract
salary: $65 - 70 per hour
work hours: 8am to 4pm
- 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 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 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.
- BS in Technical Field (engineering, building sciences, life science or equivalent).
- 10 years technical experience.
- 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.
- Experience level: Experienced
- Minimum 10 years of experience
- Education: Bachelors (required)
- Civil (8 years of experience is required)
- pharmaceutical manufacturing (6 years of experience is preferred)
- 3D Design
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.