Department: Manufacturing
Reports To: Manufacturing Services Director
Location: Thousand Oaks CA (on site)
MAJOR ACTIVITIES AND RESPONSIBILITIES:
- Responsible for development and delivery of manufacturing training plans
- Support development and execution of long- and short-term training strategy for Manufacturing Department
- Develop qualification pathways and work with supervisors and managers within the manufacturing department to identify most efficient training strategies
- Evaluate effectiveness of training programs. Partner with internal stakeholders and SMEs to determine appropriate improvements of existing training.
- Support coordination of training resources as needed
- Manage materials needed to support training program to ensure inventory levels and their traceability
- Collaborate with manufacturing department leaders in the execution of training deliverables
- Author owns review and approves manufacturing training documents as needed
- Supports ownership of investigations implementation of change controls and CAPAs associated with training as needed.
- Collaborate with manufacturing process owners on Aseptic Operator Qualification (AOQ) program ensuring it remains relevant over time
- Active participant in the New Product Introduction (NPI) sub-team meetings to assess impact to current training curricula and to develop training strategies to ensure readiness of manufacturing staff
- Support regulatory and client inspections
ORGANIZATIONAL STRUCTURE:
This position is an individual contributor role reporting to Manufacturing Services Sr. Manager. Its a in-person role within our Manufacturing Department
BACKGROUND REQUIREMENTS (Education & Professional Experience):
- Master of Science (.) with 3 years of relevant experience in aseptic processing with emphasis in cell therapy manufacturing
- Bachelor of Science (.) with 5 years of relevant experience in aseptic processing with emphasis in cell therapy manufacturing
- Associates degree with 6 years of experience of relevant experience in aseptic processing with emphasis in cell therapy manufacturing
- High School diploma with 7 years of direct experience in cell therapy manufacturing
- Working knowledge of cell therapy manufacturing aseptic processing
- Working knowledge of technical writing EMA and FDA regulations and inspection readiness
- Working knowledge of contamination controls and Quality Management Systems
- Basic knowledge of FMEA and risk management
- Proficient on analytical interpersonal verbal and written communication skills.
- Advance knowledge in Microsoft system applications (Word Excel PowerPoint Project).
- Proficient in critical and logical thinking with ability to analyze problems identify alternative solutions and implement recommendations for resolution.
- Self-motivated flexible able to prioritize multi-task and work in a fast-paced and demanding environment.
- Proficient on taking ownership of a given assignment proactively consulting cross-functional team members and other department representatives for information or guidance as necessary.
- Proficient on organizational and project management skills.
- Working knowledge on continuous improvement
- Role model for company core values of trust delighting our customers Gemba and Genki.
WORK ENVIRONMENT:
This role will require occasional entrance into a GMP facility which is governed by regulatory agencies in which there are specific requirements for hygiene and acceptable clothing. The following items are restricted when accessing the GMP manufacturing area: makeup painted nails hair products (spray gel wax) perfume and/or cologne jewelry.
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PHYSICAL REQUIREMENTS:
- Work is generally performed in an office environment.
- Donning of gowns requires ability to physically don gowns while balancing in a cleanroom environment.
- May be required to work weekends and some holidays
The US salary range for this position is $90000 to $112000. Pay within this range varies by work locationand may also depend on job-related knowledge skillsand experience.
To all agencies: Please no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email the internet or in any form and/or method will be deemed the sole property of FUJIFILM unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired no fee or payment of any kind will be paid.
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