Senior Facilities Engineer, Sterile

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