Senior Manufacturing Specialist
About The Position
Responsible for leading technical support activities for GMP Manufacturing Operations in a multi-product, large scale, biopharmaceutical facility. This role involves supporting new product introductions, process changes, drafting manufacturing records and procedures, and serving as a technical subject matter expert. The specialist will coach and mentor manufacturing associates, support trainers, and provide process support during shop floor execution. They will engage with the manufacturing team to identify areas for improvement and drive projects with significant process improvement impact. Additionally, the role includes leading corrective and preventive action implementations, partnering with Compliance/QA for deviation investigations, and supporting Operational Excellence initiatives such as error proofing, standardization, 5S, and Lean Manufacturing. The position also requires supporting safety initiatives and quality requirements.
Requirements
- Requires minimal direction or supervision to execute against routine tasks.
- Fluent in English with excellent written and verbal communication skills are required.
- Must be detail oriented, have good time management skills and be customer focused
- Must be organized and able to focus in a face-paced, multi-tasked environment and maintain operational efficiency and positive demeanor.
Nice To Haves
- Demonstrated knowledge of downstream operations is preferred, cell culture and/or fermentation
- Experience in single-use platform technology is preferred
- Bachelor’s degree in a related scientific or engineering discipline preferred with 6+ year’s related experience and/or training; or equivalent experience
Responsibilities
- New Product/Process Introduction and Changes including: Facility Fit support
- Manufacturing Record and procedure drafting
- Equipment procurement or modification
- Training generation
- Drafting, routing, and revision of manufacturing batch records, procedures, supporting records.
- Serve as technical SME in manufacturing operations, coaching and mentoring manufacturing associates, supporting trainers in development of TRNs
- Manufacturing process support during on-going shop floor execution.
- Engage with Manufacturing Associates and Supervisors to understand barriers to success, identify opportunities for improvement.
- Drive and manage projects with significant process improvement impact
- Lead implementations for corrective and preventive actions.
- Partner with Compliance/QA for timely Deviation Investigation completion
- Support activities associated with Operational Excellence Initiatives including: Error Proofing, Standardization, 5S, Lean Manufacturing
- Support safety initiatives, compliance & quality requirements.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
