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, including Microsoft Project, Word, and Excel.
- Familiar with AutoCad
- Job assignments are complex in nature and require excellent planning, project leadership, technical skills, and communication to be successful in meeting project objectives. The Manager must be able to coordinate and resolve both interpersonal and technical problems and work independently.
- Comfortable working in production environment with multiple priorities. Works effectively as a team member or as a team leader.
- Hands-on ability to isolate problems and identify root cause of issues.
- Ability to acquire data, to organize, to analyze, and reach accurate conclusions.
- Working knowledge of statistical methods used to develop metrics.
- Ability to teach others how to fix things, ability to analyze data to identify trends and establish corrective actions.
- Understanding of engineering principles as they apply to facility and production equipment.
- Understanding of maintenance and calibration strategies and techniques. Understanding of Continuous Improvement Principles.
- Understanding of engineering principles as they apply to scientific instruments.
- Experience with Process systems and equipment such as filters, pumps, tanks, mixers, autoclaves, fillers, cappers, clean rooms, labelling and packaging equipment etc
- General knowledge of Plant Utility systems and equipment such as vacuum pumps, compressors, chillers, boilers, etc
- General knowledge of HVAC systems such as air handlers, chillers, heat exchangers
- Detailed knowledge of Process Control and Instrumentation Systems.
- General knowledge of sanitary piping principles including pipe specification, valve configuration, pump setup, etc.
- Knowledge of OSHA requirements and understanding of cGMP, GDP, and FDA requirements as they apply to processing. Experience with regulatory interaction/auditing. Experience with Validation and Investigation Reporting.
- Ability to understand mechanical layouts and electrical/pneumatic schematics (P&ID’s).
- Experience with internal customer interaction and coordination.
Physical Environment and Requirements
- Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.
- Employee must be able to occasionally lift and/or move up to 25 pounds.
- While performing duties of the job, incumbent is occasionally required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear
American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. Applicants have rights under Federal Employment Laws.
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- Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf
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