Senior Facilities Engineer

Amneal

1d • $110,000 - $115,000

About The Position

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.

Requirements

• Bachelors Degree (BA/BS) Engineering, Manufacturing or related fields - Required
• 5 years or more in Facilities management, engineering, or a related field within the pharmaceutical or life sciences with 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.
• This position requires successful completion of an OSHA-compliant Respirator Fit Test.

Nice To Haves

• Master Degree (MS/MA) Engineering, Manufacturing or relates fields - Preferred

Responsibilities

• 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.
• 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

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 1,001-5,000 employees