• Act as the lead technical consultant for medium-to-large capital investments (e.g. facility expansions, renovation and new construction). You will approve technical specifications and ensure designs meet both process requirements and regulatory standards.
• Manage the full project lifecycle from conceptual design (Basis of Design) through Detailed Design. This includes overseeing external Architecture and Engineering (A&E) firms to ensure deliverables meet site standards.
• Provide deep-dive expertise in upstream / downstream processing, clean utilities (WFI, clean steam), and HVAC / ISO cleanroom requirements.
• Partner with Project Managers to define scope, estimate costs (Class 1 – 5) and develop execution strategies that minimize disruption to ongoing commercial operations.
• Lead the technical risk assessment (FMEA) and safety reviews (HAZOP) to identify and mitigate potential design flaws or safety hazards early in the project lifecycle.
• Oversee the overall implementation schedule for assigned capital projects and take necessary action to ensure all assigned capital projects are completed and turned over to internal customers with pre-established deadlines.
• Collaborate with other manufacturing support groups including Validation, Automation, Quality, Metrology, Maintenance and MSAT.
• Demonstrated project management skills (schedule, cost, communications) and coordination of internal and external resources to execute projects in a timely and cost-effective manner.
• Capable of effectively negotiating contracts, bids and change orders with vendors or contractors.