Senior Specialist, Engineering

Role Summary

The Utility Engineer is a member of the Plant Engineering team providing direct hands-on technical support to the Durham Site. This position focuses on leading investigation of electrical system excursions, engineering maintenance, design system improvements and optimizations, and hands-on troubleshooting. The role includes input to deviation investigations, recommending corrective actions, and leading plant engineering improvement projects and productivity initiatives.

Responsibilities

• Lead investigation of electrical system excursions and troubleshoot plant electrical issues.
• Lead engineering maintenance, design improvements, and productivity enhancement initiatives.
• Provide input to deviation investigations for root cause assessment and corrective actions.
• Lead and participate in major utility equipment projects including funding, change control, integration, commissioning, and equipment qualification.
• Obtain bids, review contracts, supervise and follow up on contract work; participate in shutdown scheduling and GMP cleaning for facility shutdowns.
• Coordinate with Site Engineering and IPT production planners; attend daily shutdown meetings and ensure activities are tracked and completed.
• Provide technical support and training to mechanics and maintenance personnel; interface with safety, production, and quality groups to ensure compliance with standards.
• Lead or participate in discussions with contractors, vendors, or third parties to align with maintenance and reliability objectives.
• Participate in cross-functional teams for Engineering Operations projects and plant activities; streamline Maintenance department systems and procedures with emphasis on safety and cGMP compliance.
• Define equipment requirements and specifications; manage implementation of new equipment or modifications; lead installations and upgrades; troubleshoot processes or equipment issues.
• Work independently with priorities while contributing to a production team; hands-on troubleshooting of electrical systems and equipment site-wide.
• Assist in deviation investigations for maintenance instruments, equipment, and systems.

Qualifications

• Education – Bachelor’s degree in engineering, science, or related field.
• Required Experience & Skills
  • Five years of experience in production, calibration, and/or maintenance.
  • Strong planning, scheduling, and time management skills.
  • Working knowledge of GMP regulatory requirements for manufacturing operations.
  • Good oral and written communication skills.
  • Experience with GMP-compliant calibration and maintenance databases.
  • SAP experience related to plant maintenance and spare parts procurement systems.
  • Experience with formal problem-solving techniques (root cause analysis, FMEA, Lean Six Sigma tools).
  • Familiarity with World Class maintenance practices (PMs, RCM, PdM, etc.).
  • Proficiency in understanding functionality of all utility generation equipment (electrical distribution, clean utilities, boilers, chillers, HVAC, etc.).
  • Utility and HVAC system process improvement and optimization experience.
  • Technical writing and deviation investigation experience; problem solving and troubleshooting experience.
  • Familiarity with cgMPs and vaccine regulatory requirements.
• Preferred
  • CMMS experience related to plant maintenance and spare parts procurement systems.
  • Project management, including change control and equipment qualification.
  • SAP experience related to plant maintenance and spare parts procurement systems.
  • Experience in sterile, bulk, or finished pharmaceutical environments with current Good Manufacturing Practices.
  • Automation and manufacturing execution systems (MES), process modeling, and process improvement experience.
  • Mechanical functionality and reliability knowledge (asset management).
  • Green Belt/Black Belt Certification.
  • Professional Engineer credentials.

Skills

• Adaptability, Project Management, Process Improvement
• cGMP Regulations, Change Management, Data Analysis
• Deviation Investigations, Equipment Qualification, Maintenance Supervision
• Facility Management, Regulatory Audits, Troubleshooting
• Team Leadership, Utility Plant Operations

Education

• Bachelor’s degree in engineering, science, or related field

Additional Requirements

• Travel: 10%