Facilities and Project Engineer

Job Summary:

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. This role is critical in delivering high‑impact capital projects, optimizing facility performance, and embedding sustainability into our operations—all while ensuring compliance with global regulatory standards.

This is an exciting opportunity for an engineer who enjoys working across the full project lifecycle—from design and validation to execution and continuous improvement—within a highly regulated pharmaceutical environment.

What You’ll Do:

Project Engineering & Execution

• Support end‑to‑end execution of OSD manufacturing projects, including greenfield, brownfield, expansions, and upgrades.


• Coordinate engineering activities from conceptual design through commissioning and handover.


• Assist 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.

Validation & Compliance

• 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).

Facilities & Utilities Management

• Support the operation and maintenance of critical systems, 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.

Sustainability & Continuous Improvement

• 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.

Cross-Functional Collaboration

• 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.

Work Environment:

This role operates across corporate, manufacturing, and warehouse environments and may involve:

• Moderate to high noise levels


• Exposure to fumes, dust, gases, and industrial hazards


• Mechanical and electrical systems, elevated work areas, and operational equipment

Strict adherence to safety protocols and PPE requirements is essential.

Physical Requirements:

• Ability to stand, walk, sit, bend, stoop, kneel, crouch, and climb as needed


• Ability to lift and carry up to 50 lbs


• Ability to navigate office, lab, and plant floor environments


• Required use of PPE, including safety glasses, respirators, and safety shoes

Travel:

• Up to 5%

What You Bring:

Education & Technical Expertise

• 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

Core 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

Experience:

• Minimum 5 years of engineering experience in pharmaceutical manufacturing


• Experience in Oral Solid Dosage (OSD) environments preferred

Why Join Us?

• Lead impactful capital projects and facility improvements


• Work on cutting‑edge, sustainability‑focused engineering initiatives


• Gain exposure to end‑to‑end project lifecycle execution


• Be part of a collaborative team focused on quality, compliance, and innovation