An exceptional opportunity for a delivery-focused Project Engineer to join a state-of-the-art manufacturing site. The site is embarking on a major expansion on their manufacturing line. You will take full end-to-end lifecycle ownership of CAPEX and operational projects from initial concept through to final qualification and handover.
Key Responsibilities
Drive the full lifecycle execution of capital engineering projects for a brand-new Fill Finish manufacturing line including scope design, schedule management, CAPEX tracking, risk mitigation, and formal handover.
Provide expert oversight across complete Fill Finish process platforms, encompassing compounding, filling, lyophilization (LYO), and secondary packaging systems, as well as supporting utilities and automation systems.
Partner closely with site QA, Validation, Manufacturing, Supply Chain, and EHS teams to drive design reviews, hazard assessments (HAZOP), design documents (URS), and change control processes.
Ensure all execution aligns strictly with cGMP, GDP, FDA, and EMA guidelines, supporting C&Q activities and maintaining audit-ready documentation through final validation stages.
Skills, Attributes & Experience
Bachelor's degree in Engineering (Mechanical, Chemical, Process, or equivalent)
Proven track record of delivering end-to-end pharmaceutical engineering projects, with direct expertise in Fill Finish operations (compounding, filling, LYO, and packaging).
Deep knowledge of cGMP, validation frameworks, and regulatory requirements, paired with proficiency in project management software (e.g., MS Project, Primavera).
Strong stakeholder management skills to lead matrixed project teams and external vendors toward aggressive project milestones
