Sterile Facilities Engineering Lead

RXinsider LTD.; Town of Brookhaven, Northern (NY, KY); Hybrid; USD 110,000 - 115,000; Full time

Benefits offered by this job

Health and Dental Insurance

401(k) Matching

Flexible Benefits

Job summary

Amneal is seeking a Senior Facilities Engineer in New York to lead construction, utilities, and equipment installation for our sterile facility, ensuring systems meet design and regulatory requirements.

You will oversee qualification activities (IQ/OQ/PQ), manage timelines and budgets, develop preventive maintenance, and drive continuous improvement through SOPs and CAPA.

This role requires 5+ years in pharma facilities, strong project management, and knowledge of cGMP and FDA standards.

Qualifications

• 5+ years in facilities management, engineering, or related field within pharmaceutical or life sciences with sterile/aseptic facilities.
• Strong project management and leadership skills.
• Excellent communication and problem-solving abilities.

Responsibilities

• Lead facility infrastructure construction and utilities installation projects with budgets and timelines.
• Oversee qualification activities (IQ/OQ/PQ) and validation planning for new constructions and equipment.
• Maintain preventive maintenance programs and SOP updates; drive CAPA as needed.
• Ensure compliance with local regulatory requirements including fire, building, and public health authorities.
• Create training materials and support maintenance strategy improvements.

Education

Bachelor's degree in Engineering/Manufacturing or related fields

Master's degree in Engineering/Manufacturing or related fields

Job description

Amneal is seeking a Senior Facilities Engineer in New York to lead construction, utilities, and equipment installation for our sterile facility, ensuring systems meet design and regulatory requirements.

You will oversee qualification activities (IQ/OQ/PQ), manage timelines and budgets, develop preventive maintenance, and drive continuous improvement through SOPs and CAPA.

This role requires 5+ years in pharma facilities, strong project management, and knowledge of cGMP and FDA standards.