Title: 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
The presently-anticipated base compensation pay range for this position is $92,500 to $115,000 annualy. 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.
The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
Notice to Agency and Search Firm Representatives:
Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.