Description:
The Project Engineer supports engineering projects related to sterile/aseptic manufacturing, including facility construction, utility upgrades, modifications, and new equipment installations. This role assists with project activities from planning through execution while following safety, quality, and regulatory requirements.
Schedule:
1st Shift 8am - 4:30pm Monday to Friday
Essential Functions:
- Supports and executes capital and sustainment projects from scope development through turnover, maintaining project schedules, budgets, and Req/PO activity to ensure on time, cost controlled delivery. Coordinate cross functional actions across Engineering, Maintenance, Operations, Quality, and Validation, managing project risks, and preparing capital justification packages that clearly define scope, benefits, costs, and regulatory impact.
- Supports equipment installation, commissioning, and qualification activities (IQ/OQ) for manufacturing equipment, utilities, and facility systems to ensure readiness for production. Coordinate the completion of turnover packagesincluding as builts, vendor documentation, spare parts lists, calibration requirements, and preventive maintenance plansand partner closely with Maintenance and Operations to verify equipment readiness, assist with start up troubleshooting, and drive timely closure of punch list items.
- Ensure engineering activities are executed in full compliance with cGMP/FDA requirements, site EHS standards, and construction safety expectations. Support compliant change implementation by initiating and contributing to change controls, assisting with SOP updates, and preparing training materials. Assist document deviations and anomalies and drives closure of assigned CAPA actions through evidence gathering and coordination with cross functional stakeholders.
- Support the review and updating of P&IDs, drawings, layouts, and engineering specifications to ensure alignment with field conditions and document control requirements. Assist with new asset induction by creating asset records, defining preventive maintenance tasks, identifying critical spares, and coordinating spare parts tracking to improve equipment reliability. Maintain traceable engineering records and support the upkeep of the engineering document library.
- Support vendor onboarding, coordinate contractor site activities, and ensure safe execution (permits, access, schedules, escorts, safety requirements). Serve as a point of contact for vendor documentation, field coordination, and execution readiness.
- Maintain engineering KPIs/metrics (e.g., schedule adherence, PO aging, DEV/CAPA closure, document status) and build simple reporting tools for leadership visibility.
Additional Responsibilities:
- Occasional domestic and international travel is required for vendor site visits and FATs. Flexibility to work split shifts, off-hours, and weekends may be required based on business needs.
Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.
Education:
- Bachelors Degree (BA/BS) Engineering (Civil, Mechanical, Chemical, Construction Management, or related field) - Required
Experience:
- 3 years or more in Experience in engineering roles within a GMP manufacturing environment/Life science with a sterile/aseptic facility
Specialized Knowledge:
- MS Office tools such as Word, Excel, and PowerPoint.
- Reviewing and interpreting MEP/Architecture drawings and P&ID.
- Proven project management and leadership skills.
- Strong understanding of cGMP, FDA regulations, and other relevant standards.
- Exceptional problem-solving and decision-making abilities.
- Strong communication and interpersonal skills to facilitate collaboration across teams.
- AutoCAD 2D/3D and Project Management software
Additional Requirement: This position requires successful completion of an OSHA-compliant Respirator Fit Test.
The base salary for this position ranges from $95,000 to $110,000 per year. Amneal ranges reflect the Companys good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that helps you enjoy your career alongside lifes many other commitments and opportunities.