Engineering Project Manager

Job Description

Our client, a leading biopharmaceutical company that develops and manufactures biologically sourced Active Pharmaceutical Ingredients, is looking to hire an Engineering Project Manager. The incumbent is responsible for planning, administering, and completing assigned projects which may cross several functional areas. The Engineering Project Manager provides engineering guidance, planning, budgets, managerial reports and technical support for active pharmaceutical ingredient processes, and facility projects. This requires experience in design, construction and management of facility expansions and equipment installations.

Responsibilities include:

• Provide engineering guidance and project management to complete assigned engineering projects starting with development of project scope through detail designing, budgeting, funding approval, project scheduling, construction completion and/or equipment installation, start-up commissioning, validation, and documentation.
• Leads process and equipment changes to achieve production requirements.
• Analyze production and utility equipment operations, routine maintenance, and energy requirements of pharmaceutical manufacturing systems to optimize economical operation and meet regulatory requirements.
• Develop design (process, facility, etc.) parameters for the manufacture of active pharmaceutical ingredients, including equipment and facility specifications.
• Develop funding justification, seek approval, and then accomplish and control projects within funding approval.
• Provide scope, hire, manage, supervise, review, and seek authorization of contracts for consulting engineering firms and construction contractors to accomplish the actual changes of processes, equipment, and facilities.
• Supervise installation, start-up, commissioning, and support validation of processing equipment.
• Document performance of processing systems to achieve validation and compliance with QA and other regulatory requirements and agencies.
• Design tests and methods to analyze process and utility conditions to optimize operational efficiencies and/or to meet defined process and product specifications.
• Effectively manage multiple projects at the same time.
• Lead cross-functional, data-driven troubleshooting of process and utility upsets using 5-Why, Ishikawa, FMEA, and A3/DMAIC; convert findings into durable CAPAs.
• Optimize process and clean utilities (WFI/RO, clean steam, compressed air/N₂, cleanroom HVAC pressure cascades) to improve yield, uptime, and energy/water intensity.
• Design and execute DOEs to tighten control of CPPs/CQAs; translate results into setpoints, tolerances, and alarm limits with documented rationale.
• Establish and maintain SPC/CPV trending and simple dashboards; act on signals (trend shifts, OOS/OOT) with timely investigations.
• Institutionalize gains through cGMP change control: update URS/specs, redlines/as-builts, SOPs, and training; ensure re-qualification (IQ/OQ/PQ) where required.
• Strengthen asset reliability via criticality analysis and CMMS-backed PM/PdM (e.g., vibration, thermography), and close out punch lists with pristine documentation.

Job Requirements and Qualifications:

• Bachelor’s degree in engineering required (mechanical or chemical preferred). Working toward WI Professional Engineer License with FE Test
• 5 plus years of experience required; 10 plus years of experience preferred