Manufacturing Training Specialist

FUJIFILM Holdings America Corporation; Thousand Oaks (CA); On-site; USD 90,000 - 112,000; Full time

Job summary

A leading company in biotechnology seeks a Manufacturing Training Specialist at its Thousand Oaks facility. This role involves developing manufacturing training plans, supporting aseptic processing training, and ensuring regulatory compliance. A collaborative workplace culture emphasizes quality in developing life-changing cell therapies.

Qualifications

• 3+ years relevant experience in aseptic processing for M.Sc. candidates.
• 5+ years experience for B.Sc. holders in cell therapy.
• 7+ years experience required with a High School diploma in cell therapy manufacturing.

Responsibilities

• Develop and deliver manufacturing training plans.
• Evaluate effectiveness of training programs with stakeholders.
• Manage materials needed for training program.

Skills

Analytical skills

Interpersonal skills

Verbal communication

Written communication

Critical thinking

Organizational skills

Project management

Flexibility

Education

Master of Science (M.Sc.)

Bachelor of Science (B.Sc.)

Associate degree

High School diploma

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Microsoft Project

Job description

Position Overview

The Manufacturing Training Specialist works as part of the Manufacturing team supporting team goals to deliver high quality Cell Therapy Products. This Specialist supports the site contamination control strategy, including site Contamination Control Policy, Aseptic Coaching and training programs within our facility.

Company Overview

At FUJIFILM Diosynth Biotechnologies California, we’re driving the future of medicine with the expertise to produce life-changing cell therapies like T-cell and CAR T immunotherapies. Working with pioneering biotech partners, our teams manufacture innovative treatments that improve lives.

Join us at our advanced Thousand Oaks facility, where you’ll make a tangible impact on groundbreaking therapies. We offer a collaborative, flexible workplace and a vibrant culture driven by passion and energy—what we call Genki. If you’re ready to reimagine the future of healthcare, let’s create something extraordinary together.

Our campus is in Thousand Oaks, California, an exceptional place to live with great schools, natural beauty, outdoor activities, and proximity to Los Angeles and Santa Barbara.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Job Description

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. It’s a in-person role within our Manufacturing Department

BACKGROUND REQUIREMENTS (Education & Professional Experience):

• Master of Science (M.Sc.) with 3+ years of relevant experience in aseptic processing with emphasis in cell therapy manufacturing
• Bachelor of Science (B.Sc.) 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 $90,000 to $112,000. Pay within this range varies by work locationand may also depend on job-related knowledge, skills,and 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.

*#LI-Onsite

EEO Information

Fujifilm is committedto providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([e-mail]).