Utilities Engineer

Long term Contract (Opportunity for hire full time)

The Clean Utilities Engineer serves as a key support to the site Subject Matter Expert (SME) for GMP Utilities systems, including Purified Water (PW), Water for Injection (WFI), Clean Steam, and associated ancillary systems. This role has dual responsibility: supporting the project phase of the new manufacturing line and providing day-to-day operational support for the site’s three existing manufacturing lines. The position ensures utilities systems operate reliably, cost-effectively, and in full compliance with regulatory and company requirements.

• Act as a core member of cross-functional project team responsible for the design, construction, commissioning, qualification, start-up, and operational readiness of all GMP Utilities.
• Provide technical input and oversight to ensure utilities systems meet GMP, regulatory, and site requirements.
• Support transition from project execution to steady-state operations.

• Ensure effective, reliable, and cost-efficient operation of site GMP Utilities and associated ancillary systems.
• Maintain utilities systems in a compliant, in-control, and fit-for-use state to meet all site operational needs.
• Monitor utilities performance and maintain KPIs to drive operational excellence.
• Lead investigations of out-of-specification (OOS) or adverse trends, performing root cause analysis (RCA) and implementing effective CAPAs.
• Develop and maintain written operating and maintenance instructions to ensure systems operate within validated and controlled parameters.
• Implement efficient maintenance and reliability strategies in collaboration with maintenance and operations teams.
• Lead troubleshooting of equipment failures and guide operations personnel in resolving process and utilities-related issues.
• Provide technical support to maintenance and operations as required.
• Communicate effectively with internal customers and provide timely consultation and notifications related to utilities issues.
• Support internal and external inspections, audits, and investigations, including Quality and HSE engagements.
• Maintain strong communication and collaboration with site customer groups.

• Proficiency with Track Wise, Veeva Vault, and CAPA management systems.
• Experience with maintenance and computerized maintenance management systems (CMMS).

• Bachelor of Science (B.S.) in Chemical Engineering or Mechanical Engineering.
• Minimum of 7 years of engineering experience in the pharmaceutical industry.
• Strong knowledge of GMP utilities systems and regulatory expectations.
• Demonstrated expertise in RCA, CAPA development, and cross-functional collaboration.

• Role is fully onsite in Concord, North Carolina.
• Must be flexible to support production schedules, shutdowns, and other operational needs as required.

Eight Eleven Group (Brooksource) provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws.