Facilities Project Engineer

Amneal•Yaphank, NY

19h•Onsite

About The Position

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.

Requirements

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 packages—including as builts, vendor documentation, spare parts lists, calibration requirements, and preventive maintenance plans—and 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.

Nice To Haves

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.

Responsibilities

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 packages—including as builts, vendor documentation, spare parts lists, calibration requirements, and preventive maintenance plans—and 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.