Responsible for leading technical support activities for GMP Manufacturing Operations in a multi-product, large scale, biopharmaceutical facility.
Job Responsibilities include, but are not limited to, the following:
- 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.
Knowledge, Skills, Abilities
- 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
- 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.
Working Conditions
The job requires supporting a 24-hour manufacturing facility which may include on call phone support or support overnight and on weekends. The job requires working within a cGMP manufacturing biotechnology facility which requires clean room operations. Clean room operations require donning clean room attire when entering clean room areas and maintaining good personal hygiene. While performing the duties of this job the employee may use equipment and materials which include mechanical hazards, chemical hazards, electrical hazards, and tripping and falling hazards. The noise level in the manufacturing environment is moderate to high, however, employee will routinely work in office area.
