We are seeking an experienced Process / Cleaning Project Engineer to lead major equipment packages for a large-scale capital expansion project. In this role, you will oversee the end-to-end lifecycle-from initial design and vendor selection through installation, verification, and site integration-for oral solid dosage (OSD) manufacturing and cleanroom processing equipment. You will serve as the technical focal point, driving cross-functional alignment, managing vendor performance, and ensuring projects are delivered safely, on schedule, and within budget.
Key Responsibilities
- Project & Team Leadership: Drive multidisciplinary project teams, vendors, and engineering contractors to safely execute cleanroom processing equipment packages (e.g., blending, granulation, tableting, dispensing, and equipment washers/cleaning systems).
- Engineering & Lifecycle Management: Oversee the full qualification lifecycle, including User Requirement Specifications (URS), Engineering Specifications, Design Qualifications (DQ/DR), Design Risk Assessments, and verification activities (FAT, SAT, IQ, OQ, PQ, PV/CV).
- Cross-Functional Coordination: Manage critical interfaces across process, electrical, automation, facilities, utilities, and IT/OT teams to coordinate utility hookups, layout reviews, P&IDs, and operational integration.
- Cost & Schedule Control: Build and track detailed project timelines (Gantt charts) and manage the package budget, change controls, and financial reporting.
- Risk Management & Quality: Proactively identify and mitigate technical and operational risks at every stage of design, build, and implementation.
- Vendor & Stakeholder Engagement: Lead regular review meetings with equipment suppliers, conduct factory acceptance testing (FAT), and present project updates to internal stakeholders.
Key Requirements & Competencies
- Education: Bachelor's degree in Engineering, Science, or a related technical discipline (or equivalent experience).
- Experience: 6-10+ years leading cross-functional engineering project teams within regulated industries. Prior experience in Pharmaceutical OSD (tableting) manufacturing is highly advantageous; experience in Biologics or Medical Devices will also be considered.
- Core Skills: Proven track record in pharmaceutical capital expansion, equipment validation (VMP/VPL), vendor management, and budget tracking.
- Mobility: Willingness to undertake periodic business travel for vendor FATs and design reviews.
- Key Behaviors: Strong interpersonal and communication skills, adaptability in fast-paced environments, collaborative leadership, and a results-driven, problem-solving mindset.
