Project Engineer

Project Engineer

The Project Engineer will support major capital investment projects within a highly regulated pharmaceutical manufacturing environment. The role will lead engineering activities associated with manufacturing equipment, utilities, cleanrooms, and facility renovations. The position will coordinate design, construction, procurement, commissioning, qualification, and project closeout activities. The ideal candidate will have strong project management, construction coordination, GMP, and aseptic manufacturing experience. The role will also manage project schedules, costs, funding, contractors, and cross functional stakeholders.

Key Responsibilities:

• Lead capital investment projects involving manufacturing equipment, facilities, utilities, cleanrooms, and associated infrastructure.
• Support capital funding definition, preliminary engineering, detailed design, procurement, construction, commissioning, and project closeout.
• Develop integrated project schedules and resource estimates and track project progress throughout execution.
• Lead design reviews with engineering teams, subject matter experts, vendors, contractors, and other project stakeholders.
• Manage contractors, construction partners, architectural firms, vendors, and major trades throughout project execution.
• Track project budgets, capital and expense spending, cost forecasts, and cash flow against approved project plans.
• Develop capital funding requests and provide regular financial and project status updates.
• Control and track project changes throughout execution.
• Coordinate shutdown activities with internal and external stakeholders.
• Support equipment and facility commissioning, pharmaceutical qualification, and validation activities.
• Participate in HAZOP activities and monitor construction safety performance.
• Lead final project walkdowns, punch list completion, and contractor turnover activities.
• Ensure project activities comply with GMP, regulatory, engineering, and construction safety requirements.

Required Qualifications:

• Bachelor's degree or diploma in Engineering, Science, Production, or Construction Management.
• Minimum 10 years of relevant engineering, project management, or construction management experience.
• Minimum 5 years of pharmaceutical industry experience or experience within a highly regulated industry.
• Strong capital project and construction management experience.
• Experience managing large scale capital projects valued above $10 million.
• Strong understanding of GMP pharmaceutical manufacturing and aseptic manufacturing environments.
• Experience managing project budgets, capital funding, cost tracking, and cash flow.
• Experience developing and managing detailed project schedules.
• Technical understanding of HVAC, clean utilities, black utilities, electrical systems, and process equipment.
• Experience managing contractors, vendors, construction management teams, and design partners.
• Experience with commissioning, qualification, and validation of pharmaceutical equipment and facilities.
• Strong understanding of construction and process safety requirements, including HAZOP participation.
• Strong communication, presentation, reporting, negotiation, and stakeholder management skills.

Preferred Qualifications:

• Experience managing fill finish and packaging equipment projects.
• Experience managing large scale pharmaceutical construction and facility fit out projects.
• Strong mechanical engineering background.
• Experience with cleanroom construction and pharmaceutical utilities.
• Experience with sterile or aseptic manufacturing environments.
• Experience with equipment procurement and vendor contract management.
• Experience with projects valued significantly above $10 million.

Benefits:

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)