We are seeking a delivery-focused Contract Project Engineer / Project Manager to lead end-to-end engineering projects supporting biopharmaceutical manufacturing, facility upgrades, tech transfers, and process improvements. This role requires a hands-on technical lead who can seamlessly coordinate cross-functional site teams and external vendors to deliver projects safely, on time, and in strict compliance with global regulatory standards.
- Key Deliverables
- End-to-End Project Ownership: Define project scopes, manage schedules and CAPEX budgets, mitigate risks, and lead successful handovers.
- Technical Engineering Expertise: Provide oversight across process equipment, utilities, and automation systems. Develop URS/design documents and review drawings and FAT/SAT protocols.
- Cross-Functional Alignment: Partner with QA, Validation, Manufacturing, and EHS to drive design reviews, hazard assessments (HAZOP), and robust change controls.
- C&Q and Compliance: Ensure all execution aligns with GMP/GDP, FDA, and EMA guidelines. Support commissioning, qualification, and maintain audit-ready project documentation.
- Commercial & Vendor Management: Prepare capital justifications, track costs, and manage procurement and vendor negotiations.
- What You Bring
- Industry Experience: Proven track record managing engineering projects and equipment vendors within a regulated biopharmaceutical manufacturing environment.
- Compliance & Validation: Strong working knowledge of cGMP, GDP, validation principles, and FDA/EMA/ICH regulations.
- PM Toolkit: High proficiency in project management tools (e.g., MS Project, Primavera) with excellent risk-mitigation and troubleshooting skills.
- Education: Bachelor's degree in Engineering or equivalent heavy-duty, hands-on industry experience.
- Soft Skills: Exceptional leadership and communication skills to drive matrixed, cross-functional teams toward tight deadlines.
- Apply Today
- If you are an adaptable, results-driven contractor who can hit the ground running on critical site upgrades, we want to hear from you.
