Engineering Manager

American Regent•New Albany, OH

About The Position

The Engineering Manager provides leadership and hands-on technical support for facility, utility, laboratory, and manufacturing equipment and associated instruments. As part of a multidisciplinary team, the Manager ensures engineering troubleshooting and project activities are properly staffed and supported in compliance with engineering specifications, FDA requirements, and Good Manufacturing Practices (GMP). The role serves as a subject matter expert for engineering design, construction, and commissioning and leads, directs, and develops the engineering department. It also requires effective meeting leadership, presentations to the leadership team, and clear, professional communication throughout the organization. The Manager oversees engineering operations and staff, coordinates engineering work and project schedules, supports production and laboratory operations, and maintains engineering procedures, records, drawings, and documentation. The role identifies and implements projects and improvements, supports investigations and corrective actions, and coordinates with customers, service providers, design firms, and Maintenance. The position requires technical troubleshooting and knowledge of regulated manufacturing, process equipment, utilities, HVAC, instrumentation, process control, validation, and engineering standards. The position involves working in a production environment with multiple priorities. The employee must be able to wear cleanroom and protective equipment, including respirators, and occasionally lift or move up to 25 pounds. The role may involve occasional standing, walking, sitting, handling objects or tools, reaching, balancing, talking, and hearing.

Requirements

Bachelor's degree in Engineering.
At least 8 years of experience in a pharmaceutical or similar regulated environment.
At least 5 years of leadership experience.
Proficiency with Microsoft Office applications, including Microsoft Project, Word, and Excel.
Ability to use AutoCAD; familiarity is specified.
Excellent planning, project leadership, technical, and communication skills.
Ability to coordinate and resolve interpersonal and technical problems and work independently.
Comfort working in a production environment with multiple priorities; ability to work effectively as a team member or team leader.
Hands-on ability to isolate problems and identify root causes.
Ability to acquire, organize, and analyze data and reach accurate conclusions.
Working knowledge of statistical methods used to develop metrics; ability to identify trends in data and establish corrective actions.
Ability to teach others how to fix equipment or systems.
Understanding of engineering principles applicable to facility and production equipment and scientific instruments.
Understanding of maintenance and calibration strategies and techniques, and continuous improvement principles.
Experience with process systems and equipment such as filters, pumps, tanks, mixers, autoclaves, fillers, cappers, clean rooms, labeling equipment, and packaging equipment.
General knowledge of plant utility systems and equipment such as vacuum pumps, compressors, chillers, and boilers.
General knowledge of HVAC systems such as air handlers, chillers, and heat exchangers.
Detailed knowledge of process control and instrumentation systems.
General knowledge of sanitary piping principles, including pipe specification, valve configuration, and pump setup.
Knowledge of OSHA requirements and understanding of cGMP, GDP, and FDA requirements as they apply to processing.
Experience with regulatory interactions or audits, validation, and investigation reporting.
Ability to understand mechanical layouts and electrical and pneumatic schematics, including P&IDs.
Experience with internal customer interaction and coordination.
Physical ability to wear cleanroom and protective gowning and equipment, including goggles, face shields, respirators, and protective gloves.
Ability to occasionally lift and/or move up to 25 pounds.

Responsibilities

Manage the Engineering Department.
Prepare, maintain, and follow procedures for project design, construction, and commissioning in accordance with cGMP, company, local, and state requirements.
Maintain, review, and communicate metrics; assess performance against expectations and track actions to improve performance.
Coordinate engineering activities and work schedules.
Develop, conduct, and document methods for troubleshooting engineering systems.
Identify, develop, and implement engineering projects to address business needs.
Review engineering project paperwork and develop project justifications, including payback analyses.
Work with customers to identify and implement corrective actions for out-of-specification operations and alarms.
Assess staffing levels against requirements and production needs.
Support Quality Assurance investigations of process issues and events.
Facilitate completion of change-control documentation and ensure engineering files are maintained.
Ensure facilities, utilities, HVAC, and instrumentation drawings are maintained in as-built condition.
Provide technical troubleshooting support to engineers and technicians responding to breakdowns.
Serve as site owner and subject matter expert for engineering systems.
Develop and implement improvements through cross-functional interactions.
Develop, review, revise, and maintain SOPs for engineering processes.
Assist with EHS activities when applicable and appropriate.
Supervise Engineering staff, oversee work quality, and manage staffing coverage for manufacturing and laboratory operations.
Develop and evaluate personnel, create training modules, provide coaching and feedback, and ensure training is current and effective.
Remain current on industry and FDA engineering standards and trends.
Coordinate service providers and maintain relationships with design firms; establish agreements, oversee technical quality, and ensure work meets expectations.
Coordinate equipment handover to Maintenance by gathering requirements, developing turnover packages, and delivering them to the Maintenance team.