About the Role:

The Facilities and Critical Utilities Subject Matter Expert (SME) plays a pivotal role in ensuring the optimal operation, maintenance, and validation of critical utility systems within a manufacturing environment. This position is responsible for overseeing the mechanical engineering aspects of facility utilities, ensuring compliance with industry standards and regulatory requirements. The SME will lead efforts to validate equipment and utilities to guarantee they meet stringent quality and safety standards, directly impacting production efficiency and product integrity. Collaboration with cross-functional teams is essential to develop and implement strategies that enhance utility reliability and support continuous manufacturing operations. Ultimately, this role ensures that all critical utilities are managed effectively to support the manufacturing facility's operational excellence and regulatory compliance goals.

Minimum Qualifications:

• Bachelor's degree in Mechanical Engineering or a related engineering discipline.
• Minimum of 20 years of experience in utilities operations within a manufacturing or industrial environment.
• Proven expertise in equipment validation processes and regulatory compliance standards relevant to manufacturing utilities.
• Strong knowledge of mechanical systems including HVAC, steam, compressed air, and water treatment.
• Ability to interpret technical drawings, specifications, and validation documentation.

Preferred Qualifications:

• Professional Engineering (PE) license or equivalent certification.
• Experience working in a regulated industry such as pharmaceuticals, biotechnology, or food manufacturing.
• Familiarity with industry standards such as ASHRAE, ISO, and FDA guidelines.
• Project management experience related to facility and utility system upgrades.
• Advanced training or certification in equipment validation methodologies.

Responsibilities:

• Manage and oversee the operation and maintenance of critical utility systems including HVAC, compressed air, steam, water treatment, and other mechanical utilities.
• Lead equipment validation activities to ensure all utilities and related systems comply with regulatory standards and internal quality requirements.
• Develop and implement preventive maintenance programs and troubleshooting protocols to minimize downtime and optimize utility performance.
• Collaborate with engineering, quality assurance, and production teams to support facility upgrades, expansions, and process improvements.
• Prepare and maintain detailed documentation, including validation protocols, reports, and compliance records, to support audits and inspections.

Skills:

The candidate will apply mechanical engineering principles daily to analyze, design, and optimize critical utility systems ensuring they meet operational and regulatory requirements. Utilities operations skills are essential for managing the day-to-day functionality and reliability of systems such as HVAC, steam, and water treatment, directly impacting manufacturing continuity. Equipment validation expertise is used to develop and execute validation protocols, ensuring all utility systems comply with quality and safety standards. Strong problem-solving and troubleshooting skills enable the SME to quickly address and resolve utility-related issues, minimizing production disruptions. Additionally, effective communication and documentation skills are critical for collaborating with cross-functional teams and maintaining compliance records for audits and inspections.