Senior Facilities Engineer, Sterile

Merck & Co.; Town of Brookhaven (NY); On-site; USD 110,000 - 125,000; Full time

Benefits offered by this job

Health insurance

401(k) matching

Paid time off

Job summary

Amneal is seeking a Senior Facilities Engineer to lead construction, utilities and equipment installation for a sterile facility. You will oversee qualification activities and manage project budgets, timelines and resources to deliver engineering projects effectively.

You will develop and maintain preventive maintenance programs and standardize troubleshooting procedures to maximize equipment uptime and regulatory compliance across the site.

Qualifications

• 5+ years in facilities management or engineering in pharma/life sciences with sterile/aseptic facilities.
• Strong project management and leadership capabilities.
• Solid understanding of cGMP and FDA regulations.

Responsibilities

• Lead facility infrastructure construction and utilities installation projects with scope, plan, risk assessment and budgets.
• Oversee qualification activities (FAT, IQ, OQ, PQ) and validation master plan development.
• Ensure compliance with local regulatory requirements and develop training materials for maintenance programs.

Skills

Leadership

Project management

cGMP knowledge

FDA regulations

BEAM software

Education

Bachelor's degree in Engineering

Master's degree preferred

Tools

BEAM software

Job description

Description

The Senior Facilities Engineer will lead construction, utilities, and equipment installation for the sterile facility, ensuring all systems meet design and operational requirements. This position will be responsible for overseeing qualification activities and managing project timelines, budgets, and resources to deliver engineering projects effectively. The Senior Facilities Engineer will develop and maintain preventive maintenance programs to maximize equipment uptime and establish standardized troubleshooting procedures.

Essential Functions

• Lead facility infrastructure construction and utilities installation/upgrades projects. Develop project scopes, technical plans, feasibility analysis, risk assessments, budgets, and execute aligned with business requirements. Coordinate activities related to procurement and contract management. Manage maintenance activities by executing and tracking in accordance with organization SOPs.
• Lead qualification activities, including factory acceptance test (FAT) installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) for new constructions, utilities and equipment. Support to develop validation master plan, requalification strategy and environmental monitoring performance qualification (EMPQ). Manage requalification activities per schedule and requirements. Regularly report project progress, compile project reports, analyze lessons learned, and suggest improvements.
• Oversee the performance and upkeep of facility infrastructure and critical utilities to ensure efficiency and reliability. Lead the creation of training materials to support the Facilities Maintenance training program and enhance the maintenance strategy to improve cost-effectiveness, compliance, and overall operational performance.
• Execute new and revised SOPs, ensuring timely updates aligned with operational and compliance requirements. Lead change control processes and conduct impact assessments to evaluate modifications across systems and procedures. Support investigations by identifying root causes, analyzing relevant data, and driving effective CAPA implementation.
• Ensure ongoing facility compliance with all relevant local regulatory requirements, including those enforced by fire, building, and public health authorities, through regular monitoring and proactive oversight.

Additional Responsibilities

• Provide support and coordinate tasks involving engineering construction projects. Maintain engineering documents such as layouts, spare/parts materials, design for maintainability
• Verify and develop P&ID, engineering layout, engineering drawings and engineering documents
• Assist in activities for qualification of the facilities and utilities

Education

• Bachelors Degree (BA/BS) Engineering, Manufacturing, Engineering Communications, or related fields - Required
• Master Degree (MS/MA) Engineering, Manufacturing, Engineering Communications, or related fields - Preferred

Experience

• 5 years or more in Facilities management, engineering, or a related field within the pharmaceutical or life sciences with sterile/aseptic facility

Specialized Knowledge

• 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.
• Utilizes BEAM software simulation or comparable advanced modeling tools to evaluate system performance, validate design assumptions, and support engineering decision-making.

Additional Requirement: This position requires successful completion of a OSHA-compliant Respirator Fit Test.

The base salary for this position ranges from $110,000 to $125,000 per year. Amneal ranges reflect the Company's good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that helps you enjoy your career alongside life's many other commitments and opportunities.

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 [e-mail] . Requests will be handled confidentially and in accordance with applicable laws.