Senior Facilities Engineer

Amneal•Brookhaven, NY

3d•$110,000 - $125,000

About The Position

The Senior Facilities Engineer leads construction, utilities, and equipment installation for a sterile facility, ensuring systems meet design and operational requirements. The role oversees qualification activities and manages project timelines, budgets, and resources to deliver engineering projects. It also develops and maintains preventive maintenance programs to maximize equipment uptime and establishes standardized troubleshooting procedures. The position oversees facility infrastructure and critical utilities, leads construction and installation or upgrade projects, and manages maintenance activities in accordance with organizational SOPs. It leads qualification work for new construction, utilities, and equipment, including FAT, IQ, OQ, and PQ, and supports the development of validation and requalification strategies. The engineer also supports compliance, change control, investigations, training, and continuous improvement activities. This position works first shift, 8:00 a.m. to 4:30 p.m., Monday through Friday. Successful completion of an OSHA-compliant Respirator Fit Test is required.

Requirements

Bachelor’s degree (BA/BS) in Engineering, Manufacturing, Engineering Communications, or a related field.
At least 5 years of experience in facilities management, engineering, or a related field within pharmaceutical or life sciences, involving a sterile/aseptic facility.
Strong understanding of cGMP, FDA regulations, and other relevant standards.
Proven project management and leadership skills.
Exceptional problem-solving and decision-making abilities.
Strong communication and interpersonal skills to facilitate collaboration across teams.
Proficiency in relevant engineering software and tools.
Experience utilizing BEAM software simulation or comparable advanced modeling tools to evaluate system performance, validate design assumptions, and support engineering decision-making.
Successful completion of an OSHA-compliant Respirator Fit Test.

Nice To Haves

Master’s degree (MS/MA) in Engineering, Manufacturing, Engineering Communications, or a related field.

Responsibilities

Lead facility infrastructure construction and utilities installation or upgrade projects; develop project scopes, technical plans, feasibility analyses, risk assessments, and budgets, and execute projects in alignment with business requirements.
Coordinate procurement and contract management activities.
Manage maintenance activities and track their execution in accordance with organizational SOPs.
Lead qualification activities, including FAT, IQ, OQ, and PQ for new construction, utilities, and equipment.
Support development of the validation master plan, requalification strategy, and environmental monitoring performance qualification (EMPQ).
Manage requalification activities according to schedules and requirements.
Report project progress, compile project reports, analyze lessons learned, and recommend improvements.
Oversee the performance and upkeep of facility infrastructure and critical utilities to ensure efficiency and reliability.
Lead creation of training materials for the Facilities Maintenance training program and improve maintenance strategy, cost-effectiveness, compliance, and operational performance.
Execute new and revised SOPs and ensure timely updates aligned with operational and compliance requirements.
Lead change control processes and conduct impact assessments for modifications across systems and procedures.
Support investigations by identifying root causes, analyzing relevant data, and driving CAPA implementation.
Monitor facility compliance with applicable local regulatory requirements, including requirements enforced by fire, building, and public health authorities.
Support and coordinate engineering construction project tasks.
Maintain engineering documents, including layouts, spare-parts materials, and design-for-maintainability documentation.
Verify and develop P&IDs, engineering layouts, drawings, and other engineering documents.
Assist with qualification of facilities and utilities.