Senior Facilities Engineer, Pharma Sterile Systems Lead

Amneal Pharmaceuticals; Town of Brookhaven (NY); On-site; USD 110,000 - 125,000; Full time

Job summary

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

You will manage qualification activities (IQ/OQ/PQ/FAT), develop validation strategies, maintain preventive maintenance programs, and drive compliant, cost-effective operations across projects while leading cross-functional teams and reporting progress to stakeholders.

Qualifications

• Bachelor’s degree in Engineering or related field.
• Master’s degree in Engineering or related field preferred.
• 5+ years in facilities management/engineering within pharma or life sciences with sterile/aseptic facility.

Responsibilities

• Lead facility infrastructure construction and utilities installation/upgrades projects.
• Lead qualification activities (FAT, IQ/OQ, PQ) and develop validation strategies.
• Oversee performance and upkeep of facility infrastructure and critical utilities.
• Execute SOPs and lead change control processes; drive CAPA when needed.
• Ensure ongoing facility compliance with local regulatory requirements.

Skills

Project management

Leadership

cGMP

FDA regulations

Qualification

IQ/OQ/PQ

Validation

CAPA

Change control

SOPs

Maintenance planning

BEAM software

Education

Bachelor's degree in Engineering or related field

Master's degree preferred

Tools

BEAM software

Engineering software

Job description

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

You will manage qualification activities (IQ/OQ/PQ/FAT), develop validation strategies, maintain preventive maintenance programs, and drive compliant, cost-effective operations across projects while leading cross-functional teams and reporting progress to stakeholders.