Reporting to the Project Manager, you will lead a multi-disciplinary team responsible for delivering the project scope of an API facility through to Commissioning and Qualification (CQ). You will coordinate activities across Design, Construction, Process, Automation, Tech Ops, C&Q, Operations, and QA, bridging the gap between the Client, EPCM, and Trade Partners.
- Key Responsibilities
- Scope & Strategy: Define physical/procedural scope boundaries for the facility suites. Develop and execute project plans adhering to safety, schedule, cost, and performance standards.
- Cross-Functional Coordination: Align design efforts with the contract engineering firm to ensure compliance with local and global standards. Facilitate engineering and user requirements.
- Design & Technical Review: Lead owner-side reviews of layouts, P&IDs, process descriptions, change controls, and datasheets. Participate in Value Engineering.
- Project Controls: Track progress, manage budgets, and resolve scope/schedule issues. Lead daily alignment meetings and handle change management within a strict GMP Quality System.
- EHS Leadership: Champion a zero-injury safety culture throughout the design, construction, C&Q, and handover phases.
- Skills & Experience
- API Expertise: In-depth understanding of large-scale API projects, unit operations, and C&Q documentation for cGMP process equipment.
- Project Management: High proficiency in PM tools, critical path analysis, and financial/resource tracking.
- Automation: Working knowledge of process control systems (DeltaV and BMS experience a plus).
- Leadership: Proven track record of managing multi-functional teams, resolving conflicts, and driving accountability for project milestones.
- Job Requirements
- Education: Bachelor's degree in Engineering, Science, or a related technical discipline.
- Experience: 10+ years of project management experience on large-scale Pharmaceutical projects, with significant experience managing API facilities.
- Regulatory: Strong working knowledge of FDA and EU GMP regulations.
- Communication: Exceptional interpersonal and stakeholder management skills; fluent in English.
