Position Summary

The role of Plant Engineer, Process Utilities is to ensure the reliable and compliant operation of essential support utilities (such as Clean-in-Place (CIP), glycol, compressed air, process gases, and process waste). As a key part of the Plant Engineering team, this engineer will execute projects to improve the safety, efficiency, reliability and compliance of these utility systems. They will oversee maintenance activities, coordinate system shutdowns, provide troubleshooting know-how, and lead investigations related to these systems. Members of this team serve as subject matter experts (SMEs) for these systems on project teams and during regulatory inspections. The members of this team are expected to cross-train on facility systems, but each individual will maintain specialized skill. The role will report into the Senior Manager of Plant Engineering.

Duties & Responsibilities

• Own and support manufacturing utility systems, including glycol, process waste, clean-in-place (CIP), compressed air, process gases, and others.
• Manage engineering projects to improve utility system performance and reliability.
• Coordinate project work and maintenance activities with operations to minimize disruption to manufacturing processes and laboratories.
• Execute or contribute to safety permits and job hazard analyses (JHAs) to support safe execution of work.
• Provide technical direction to maintenance technicians, outside service providers, and operations personnel.
• Partner with Facilities & Engineering teams and external vendors to implement engineered solutions.
• Review and approve technical documentation such as drawings, specifications, and SOPs to ensure accuracy and currency.
• Lead or support qualification and compliance of cGMP-critical utilities in accordance with industry regulations and company directives.
• Investigate system issues or adverse performance trends and implement corrective and preventive actions (CAPAs).
• Plan and execute orderly service interruptions and returns to service as part of quality planning.
• Collaborate with Quality Assurance and EHS teams to address compliance and safety-related concerns.
• Respond to unplanned outages and support timely resolution to minimize operational impact.
• Maintain accurate system documentation and records in alignment with cGMP and internal standards.
• Revise and maintain standard operating procedures (SOPs) related to utility systems.
• Support on-call or off-hours utility needs, including planned shutdowns or emergent issues.

Education & Experience

• BS Degree in Engineering or related discipline required. Mechanical or Chemical Engineering preferred.
• Relevant utilities engineering experience is required. Knowledge of pharmaceutical utility operation, cleanrooms, HVAC, pharmaceutical water systems and building systems is preferred.
• Understanding of applicable regulations (GMP, OSHA, DEC, etc.). Familiarity with quality systems governing GMP utilities (change control, SOPs, investigations, CAPAs).

Knowledge, Skills, Abilities

• Deep knowledge of utility systems in cGMP manufacturing environments.
• Familiarity with current industry standards and regulatory requirements for critical utilities.
• Ability to apply reliability engineering principles to improve system performance.
• Strong problem-solving, continuous improvement, and analytical skills.
• Effective communication and training skills for cross-functional teams and technical staff.
• Ability to manage vendors, coordinate across departments, and act as a subject matter expert during inspections.
• Established ability to work across organizational boundaries to resolve a range of technical and compliance issues.

Physical Demands

The position requires lifting items up to 50 pounds, frequent bending, stooping, twisting, crouching, squatting, kneeling, sitting, walking on level surfaces, repetitive use of arms, hands, and wrists, grasping, fine manipulation, reaching and working overhead at shoulder level, occasional crawling, operating a vehicle, use of foot controls, and vision acuity (color correction allowed).

Work Environment

The candidate must be willing and able to work flexible hours, including occasional evenings, weekends, or on-call shifts to support operational needs. Work primarily occurs indoors, often both independently and collaboratively with others. Occasional outdoor work may involve exposure to noise levels at or above 85 dBA (with hearing protection), extreme heat, confined or cramped spaces, heights, dust, mist, fumes, wet or damp surfaces, and infrequent contact with chemicals.

Supervisory Responsibilities

Supervision may include FTEs and contractors, including objective setting for the department.

Travel

Up to 5% travel may be required for this position.

Target Bonus

10%

Work Location:

East Syracuse, NY