Facilities and Project Engineer
About the role
We are seeking a driven and technically skilled Facilities & Project Engineer to support and lead engineering initiatives across our Oral Solid Dosage (OSD) manufacturing operations.
Responsibilities
- Support end-to-end execution of OSD manufacturing projects, including greenfield, brownfield, expansions, and upgrades.
- Career activities from conceptual design through commissioning and handover.
- Aid in CAPEX planning, budget tracking, scheduling, and change management.
- Prepare and review technical documentation, including URS, equipment specifications, layouts, P&IDs, and engineering drawings.
- Interface with OEMs, EPC vendors, contractors, and consultants.
- Prepare and execute IQ/OQ/PQ protocols and develop summary reports for production equipment and utilities.
- Support validation activities for HVAC, compressed air, boilers, purified water systems, and facility qualifications (e.g., temperature mapping).
- Ensure all activities comply with cGMP, FDA, EU GMP, WHO, and other global regulatory standards.
- Manage engineering change controls and support investigations, deviations, and CAPAs.
- Maintain audit-ready documentation and support regulatory inspections (FDA, DEA, internal audits).
- Sustain and maintain facilities, including HVAC, purified water (USP), boilers, compressed air, hot water, and electrical systems.
- Ensure facilities consistently meet FDA, OSHA, and environmental compliance standards.
- Develop maintenance strategies and plans for new and existing equipment.
- Prepare and deliver SOPs for setup, operation, cleaning, and maintenance.
- Integrate sustainable engineering practices into facility operations and projects.
- Drive initiatives to reduce energy consumption, water usage, waste, and carbon footprint.
- Monitor and report on key sustainability KPIs, including energy, emissions, and water usage.
- Lead energy audits and water balance studies.
- Align initiatives with corporate ESG goals while maintaining business efficiency.
- Support new product launches and facility readiness across NJ sites.
- Collaborate with Quality, Manufacturing, EHS, and Engineering teams to ensure seamless project execution.
- Troubleshoot technical issues and support multiple concurrent projects.
Requirements
- Bachelor’s or Master’s degree in Chemical, Mechanical, or Electrical Engineering.
- Strong technical understanding of pharmaceutical manufacturing systems and equipment.
- Knowledge of cGMP, regulatory requirements, and validation lifecycle documentation, including:
- URS, FRS, VMP
- FAT, SAT, commissioning, IQ/OQ/PQ
- Risk assessments (FMEA) and validation master planning
- Experience preparing and executing change controls, investigations, SOPs, and validation documentation.
Qualifications
- Minimum 5 years of engineering experience in pharmaceutical manufacturing.
- Experience in Oral Solid Dosage (OSD) environments preferred.
Skills
- Strong analytical and problem-solving capabilities.
- Excellent project management and organizational skills.
- Strong communication and presentation abilities.
- Proficiency in cross-functional collaboration and stakeholder management.
- A proactive, hands-on approach with a “can-do” mindset.
- Proven ability to drive innovation and continuous improvement.
- English proficiency at CEFR Intermediate B1+ level.
Benefits
The presently-anticipated base compensation pay range for this position is $92,500 to $115,000 annually. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the Long Term Incentive Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.