Position Summary | The Operations Engineering Manager is responsible for maintaining expertise with and making meaningful contributions to filling and related manufacturing operations to meet desired product specification for all BSM client projects of parenteral drug product manufacturing. The Operations Engineering Manager is responsible for broadly managing the novel creation of bespoke and general solutions for client-needs and / or quality parameter objections. This includes the management of staff, vendors, quality documentation, and functional requirements of process designs, implementation efficacy and training, and conception, fabrication, testing and induction of size or change part kits. The manager must be qualified for filling operations by media fill participation and contribute to contemporaneous process monitoring, improvement, and troubleshooting all fill related operations. |
Duties and Responsibilities | - Work with operations, engineering, QA, maintenance, suppliers and management to resolve problems
- Work with client to identify filling operation quality outcomes
- Communicate with the clients and internal departments including upper management on project status and results
- Prepare and review quality documents and reports
- Suggest and partake in continuous improvement initiatives
- Provide feedback on, and propose solutions regarding process improvement initiatives to improve operating performance
- Lead CAD-based part designs to empower process improvement
- Due diligence on process design and risk analysis to ensure operation safety, efficiency and quality
- Review MFG operations batch records and other quality documents and reports
- Review and approve study protocols to evaluate manufacturing processes and write associated summary reports
- Create documents for operation and quality such as master batch records, working closely with the quality unit.
- Develop and / or revise SOPs for equipment operations as needed
- Accurately document and record (GDP) necessary data and reports with appropriate conclusions
- Complete quality events such as deviation with sound judgement and scientific principal in a timely fashion
- Maintain expertise on equipment with many degrees of freedom and manufacturing technology changes and core process technologies
- Support daily activities in Manufacturing Operations and be able to work flexible hours and/or remain on-call for critical operations
- Create and maintain control charts, key performance metrics and trending data from assigned areas to communicate process controls and improvements
- Evaluate manufacturing processes and equipment and suggest improvements to increase reliability, throughput, minimize waste/rework.
- Work directly with manufacturing management to identify key areas of equipment and process improvement
- In conjunction with manufacturing personnel, evaluate new manufacturing equipment, prepare operating procedures and develop training.
- Oversee modifications to manufacturing equipment as required/requested by Manufacturing, manage associated change controls and work orders
- Have ownership of assigned equipment or business processes
- Maintain up-to-date timelines and meet agreed upon deadlines
- Source equipment and develop processes that meet safety requirements and provide for the safety and well-being of operators, maintenance and other personnel
- Keep up industry knowledge and provide trainings in equipment and manufacturing technology
- Other duties as assigned
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Regulatory Responsibilities | - Conduct business in a responsible manner that complies with all state, FDA, OSHA, EPA, and DEP regulations, or otherwise as applicable
- Maintain a detailed and comprehensive understanding of FDA, EU, and other regulatory agency requirements
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Supervisory Responsibilities | - Supervise/execute technology transfer of new processes or equipment
- Support daily activities in the assigned areas and be able to work flexible hours and/or remain on call for critical manufacturing operations
- Support validation activities including equipment validation and process validation
- Lead problem solving and investigate quality events related to filling operations
- Propose and lead process improvement initiatives to improve operating performance
- Supervise, mentor, and develop team members or relevant personnel across departments
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Experience | - Five plus (5 ) years' experience in aseptic processing, terminal sterilization or lyophilization desired
- In the absence of above, 5 years of hands-on work in a technical field performing research, or field work utilizing scientific or industrial equipment.
- Three plus (3 ) years of supervisory/management experience
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Education | - Advanced degree expected
- Minimum of Bachelor's degree in Chemical Engineering, Chemistry, Biology, Engineering or Pharmaceutical Science AND relevant experience
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Knowledge, Skills & Abilities
| - Expertise with 3D / CAD modeling and ANSI drafting
- Knowledge of scientific best practices
- Excellent in technical writing
- Knowledge of engineering first principles
- Knowledge of parenteral drug product development and manufacturing
- Able to work in a dynamic environment and adapt to changing priorities
- Excellence in solving complex engineering and / or scientific problems
- Able to handle multiple projects
- Expertise with Microsoft Office
- Familiar with Master Control
- Project management skills
- Excellent writing skills
- Attention to detail
- Written and oral communication skills
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Physical Requirements | - Ability to meet gowning requirements
- Ability to remain stationary for prolonged periods of time
- Ability to periodically lift up to 50 lbs.
- Satisfactory audio-visual acuity
- Gross and fine motor skills to manipulate instruments
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