Nature and Scope
The Manager provides leadership and hands on technical support for facility, utility, lab, and manufacturing equipment and associated instruments. Working as part of a multi-disciplinary team, the Manager will ensure that engineering troubleshooting or project activity is properly staffed and supported in compliance with engineering specifications, the Food and Drug Administration (FDA), and Good Manufacturing Practices (GMP) guidelines. The individual will be responsible for providing Subject Matter Expertise (SME) for all aspects of the Engineering Design, Construction, and Commissioning.
This position requires the ability to lead, direct, and grow an engineering department, chair meetings, present topics to the leadership team, provide constant, thorough and professional communication throughout all levels of the organization.
Essential Duties and Responsibilities
- Manage Engineering Department
- Prepare, maintain, and follow procedures for the Design, Construction, and Commissioning activities associated with project to adhere to cGMP's, company, local and state requirements.
- Maintain, review and communicate metrics to all levels of the organization.
- Support efforts to analyze and communicate performance against expectations, provide feedback, establish and track required actions to improve performance.
- Coordinate Engineering activities and scheduling of work.
- Develop, conduct and document methods for Engineering systems troubleshooting
- Identify, develop, and implement Engineering projects to address business needs.
- Review Engineering Project Paperwork.
- Develop Project Justifications including payback
- 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.
- Ensure that engineering files are maintained.
- Ensure that facilities/utilities/HVAC/instrumentation drawings are maintained in as-built condition.
- Provide technical troubleshooting support to engineers/technicians responding to breakdowns.
- Serve as site owner and subject matter expert of engineering systems.
- Develop and implement improvements through cross-functional interactions.
- Develop, review, revise, and maintain SOPs for all Engineering processes.
- Assist with EHS activities when applicable and appropriate.
- Supervise Engineering Staff
- Provide day to day supervision including oversight of work quality.
- Manage staffing levels to ensure coverage of manufacturing and lab operations.
- Develop training and evaluate personnel.
- Develop training modules; provide coaching/feedback to develop/enhance technical personnel capabilities.
- Ensure effective and up to date training
- Remain current on industry and FDA engineering standards and trends.
- Coordinate Service Providers
- Identify and maintain relationships with Design firms
- Establish agreements to assure support of projects.
- Oversee technical quality of work performed.
- Ensure that work performed by Design Firms meets expectations.
- Coordinate Handover of Equipment to Maintenance
- Work with Maintenance team to solicit requirements
- Develop turnover packages and deliver to Maintenance.
Education Requirements and Qualifications
Bachelor's Degree in Engineering required
Minimum 8 years of experience in Pharmaceutical or similar regulated environment
Minimum 5 years leadership experience required
Must be proficient in the use of Microsoft Office Applications, inc