Position Summary | The Senior Manager of Manufacturing Engineering is responsible for the management and oversight of a team providing technical support for aseptic filling and related manufacturing operations at Sharp Sterile. The Manufacturing Engineering team is charged with ensuring desired product specifications and quality parameters (CPPs) for BSM client projects of parenteral drug product manufacturing are met. This team empowers meeting CPPs through the creation of custom and general solutions for manufacturing filling operations, both physical parts and processes. 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 for all processes from vial washing to lyophilization / capping. The Senior Manager will promote successful execution of CAPAs and continuous improvement through the direction of the team’s subject matter experts contributions to and development of these processes. The Senior Manager must remain qualified for filling operations by successful media fill participation and contribute to contemporaneous process monitoring, improvement, and troubleshooting of all fill related operations. Limited off-shift and weekend coverage will be required based on business needs. |
Breakdown of Responsibilities (estimated percentages) | 20% | Contemporaneous Resolutions: Work with manufacturing, engineering, QA, suppliers, clients, and others to resolve problems related to filling operations. |
20% | Continuous Improvement: Design, test, and induct parts to empower filling operations as needed for business development. Refine current processes and introduce new processes. |
10% | Tech Transfer: Contribute to filling operations process design and risk analysis to ensure operational safety, efficiency, and quality. |
15% | Client Facing: Communicate with clients and internal departments including upper management as a technical SME. Work with Quality Unit to develop corrective / preventative actions for client concerns. |
10% | Sales: Provide technical expertise as liaison to sales team. |
10% | Scheduling: Provide timeline estimates to scheduling for deliverables and support feasible schedule of lots. |
5% | Accounting: Provide budgetary guidance and justification for major purchases (e.g. ROI; depreciation assessment). |
10% | Other: Review and approve Manufacturing operations batch records, protocols, studies and other quality documents and reports. |
General Expectations and Supervisory Responsibilities | - Maintain expertise on equipment and core process technologies, while staying abreast of manufacturing technology changes.
- Support daily activities in Manufacturing through staffing and flexible hours; remain on-call for critical operations
- Work directly with manufacturing management to identify key areas of
equipment and process improvement, then lead changes to implement those improvements - Perform training of personnel at various levels
- Support validation activities including equipment validation through collaboration on protocols and aid in execution
- 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
- Builds talent by recruiting, coaching, and developing the members of the Manufacturing Engineering team to ensure appropriate breadth, depth and skillset
- Manages team resources and prioritizes in alignment with business needs including business support, project support, and continuous improvement
- Provides leadership on schedule, priorities, and issue resolution to aid the team in accomplishing business objectives.
- Collaborates and engages with multiple functional organizations such as Manufacturing, Technology, Quality, Maintenance, Automation, Engineering, Procurement, Finance, Compliance, among others, to develop and maintain processes that meet cGMP and business requirements.
- Provides technical guidance to staff, colleagues or customers as well as anticipates and interprets the customer needs to identify solutions.
- Responsible for presenting technical discussions to regulatory agencies during inspections.
- Other duties as assigned
|
Regulatory Responsibilities | - Conduct business in a responsible manner that complies with all state and federal regulations, or otherwise as applicable
- Maintain a detailed and comprehensive understanding of USP, FDA, EU Annex 1, and other regulatory agency requirements
- Maintain qualification on filling operations by participating in successful media fill simulations
|
Experience | - Five plus (5 ) years' experience in aseptic processing, terminal sterilization or lyophilization desired
- In the absence of above, 5 years of demonstrated excellence in related technical field, i.e. technical or field work utilizing scientific or industrial equipment.
- Three plus (3 ) years of supervisory/management experience
|
Education | - Bachelors degree in Engineering or related sciences
- Prefer degrees in Mechanical or Chemical Engineering
|
Knowledge, Skills & Abilities | - Expertise with 3D / CAD modeling and ANSI drafting
- Knowledge of scientific best practices
- Excellent technical writing skills
- 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
- Expertise with Microsoft Office
- Familiar with Quality Management Systems
- Project management skills
- Attention to detail
- Oral communication skills
|
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
|
