Engineering Manager

American Regent, Inc.•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 appropriately staffed and supported in compliance with engineering specifications, FDA requirements, and GMP guidelines. The role serves as a subject matter expert for engineering design, construction, and commissioning. The Manager leads and develops the engineering department, coordinates engineering activities and schedules, and communicates with employees and leadership. The position oversees engineering projects, systems troubleshooting, procedures, documentation, metrics, staff development, service providers, and equipment handover to Maintenance. It also supports manufacturing and laboratory operations, Quality Assurance investigations, change control, and applicable EHS activities.

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.
Familiarity with AutoCAD.
Excellent planning, project leadership, technical, and communication skills.
Ability to coordinate and resolve interpersonal and technical problems and work independently.
Ability to work effectively in a production environment with multiple priorities, 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 analyze data, identify trends, and establish corrective actions.
Ability to teach others how to fix equipment and systems.
Understanding of engineering principles as applied 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, labelling 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 specifications, valve configurations, and pump setup.
Knowledge of OSHA requirements and understanding of cGMP, GDP, and FDA requirements as they apply to processing.
Experience with regulatory interaction or auditing, validation, and investigation reporting.
Ability to understand mechanical layouts and electrical and pneumatic schematics, including P&IDs.
Experience with internal customer interaction and coordination.
Ability to wear cleanroom or protective gowning and equipment, including goggles, face shields, respirators, and protective gloves.
Ability to occasionally lift and/or move up to 25 pounds; occasionally stand, walk, sit, handle objects, tools, or controls, reach, balance, talk, and hear.

Responsibilities

Manage the Engineering Department and coordinate engineering activities and work schedules.
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; analyze performance against expectations and track actions to improve performance.
Develop, conduct, and document engineering systems troubleshooting methods.
Identify, develop, and implement engineering projects to address business needs, including preparing project justifications and payback analyses.
Review engineering project paperwork and work with customers to implement corrective actions for out-of-specification operations and alarms.
Assess staffing levels against requirements and production needs, and ensure coverage of manufacturing and laboratory operations.
Support Quality Assurance investigations of process issues and events, and facilitate completion of change-control documentation.
Maintain engineering files and ensure facility, utility, HVAC, and instrumentation drawings are kept 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, develop and evaluate personnel, and provide training, coaching, and feedback.
Keep current with industry and FDA engineering standards and trends.
Identify and maintain relationships with design firms, establish agreements to support projects, oversee technical work quality, and ensure deliverables meet expectations.
Coordinate equipment handover to Maintenance by soliciting requirements from the Maintenance team and developing and delivering turnover packages.
Lead meetings, present topics to the leadership team, and communicate professionally throughout the organization.