Project Engineer Facilities at Amneal India

Piscataway, New Jersey, United States -

Full Time

Start Date

Immediate

Expiry Date

14 Sep, 26

Salary

110000.0

Posted On

16 Jun, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Project Management, cGMP Compliance, FDA Regulations, AutoCAD 2D/3D, P&ID Interpretation, Equipment Qualification (IQ/OQ), MEP Drawings, Change Control, CAPA, Budget Management, Vendor Management, MS Office

Industry

Pharmaceutical Manufacturing

Description

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. 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 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. 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. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at accommodations@amneal.com. Requests will be handled confidentially and in accordance with applicable laws.

Responsibilities

Supports engineering projects for sterile manufacturing, including facility construction, utility upgrades, and equipment installations. Manages project lifecycles from scope development through turnover while ensuring compliance with safety and regulatory standards.