Manufacturing Trainer, Microbial

The Manufacturing Trainer is recognized as key support with regard to training of Manufacturing Technicians in operations execution for cell culture and/or microbial upstream manufacturing processing. Delivers training to support Technicians being prepared to meet production execution schedule. Supports implementation of training for operational processes, new technology and modifications to existing technology or operational processes for the purposes of new Technician on-boarding, Technician cross-training or continuous Technician development and Production Schedule Readiness. Recognizes and Addresses where Training opportunities exist in order to achieve cost reductions, efficiency improvements, minimization of downtime and quality/safety enhancement. Collaborates inter- and intra-departmentally e.g. with MT&S, ComOps, QA, Site Training to design and deliver fit-for-purpose Training. Receives and provides feedback regarding operational and manufacturing process performance.

MAJOR ACTIVITIES AND RESPONSIBILITIES:

• In consultation with Subject Matter Experts and/or Manufacturing Leadership, Designs and/or delivers hands-on in-person training on Manufacturing Equipment Operation, Manufacturing Process Unit Operations, Manufacturing Tasks, Manufacturing Techniques and Manufacturing Small Equipment Use
• Identifies gaps and opportunities for SME training outside of own scope or expertise (e.g. specialist equipment, automation, expert techniques) and in consultation with Manufacturing Leadership and Site Training, collaborates with SMEs to plan and deliver training to Manufacturing Technicians
• Maintains awareness of Manufacturing Technician training completeness and participates in ensuring training is delivered when, where and to whom it is needed
• Maintains awareness of Manufacturing Technician training and technique consistency and supports work to harmonize, establish and implement “gold standard” in common operations and tasks
• Supports onboarding and training of new Technicians and assists with their integration into their shift, the department and familiarity with common and team-specific tasks, techniques, operations.
• Supports Continuing Development and designs, delivers or arranges training to meet the needs of existing Technicians, newly onboarded Technicians and/or Cross-Training Technicians
• Revise materials to keep pace with learning best practices and technical changes
• Support the evaluation of training courses for effectiveness using trainee feedback, area management discussions, deviation reports, etc. as sources of information and recommend improvements
• Assist area management with development and maintenance of job-specific curricula for their areas
• Support administration of Technician Level Certification and Confirmation program; including continuous improvement of the program
• Participates in deviations, CAPA, One Point Lessons and CC’s, as needed, in support of Departmental Training activities and improvements.
• Communicates with Mfg staff directly, with use of Tier 1 board, Shift Plan and Tier 2 board
• Participates in department and site level OpEx projects
• Interaction with groups such as Materials Management, Training, Commercial Operations, EHS, Maintenance, Metrology, MTS, Quality Control and Quality Assurance (QA)
• Author, review, and/or revise SOP’s, WI’s, STD lists, etc. as needed
• All other assigned duties as deemed necessary

WORKING HOURS AND LOCATION

This is an on-site position; working-from-home on occasion by arrangement. This position supports staff working seven days per week and 24 hours per day, and a minimum of 25% of the role will require in-person hands-on task and unit operation training on night shift (to be delivered between 7pm and 7am). Be available to consult via phone, zoom, and in person, when needed

BACKGROUND REQUIREMENTS:

Preferred Education, Experience and Skills - Minimum Requirements:

Prior experience and/or demonstrated aptitude to designing and delivering effective training in a cGMP manufacturing environment, including task/practical training for operations

BS/BA (science preferred) and 3 years of experience in a cGMP (pharmaceutical/manufacturing environment or

AA (science preferred) and 5 years of experience in a cGMP (pharmaceutical/manufacturing) environment

or

7 years of experience in a cGMP (pharmaceutical/manufacturing) environment

Physical Ability: ability to walk, climb stairs, crawl, kneel and lift, frequently throughout the shift, up to 12-hours.

FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization.

FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.

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.

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 10 hour shift
• 12 hour shift
• 8 hour shift

Supplemental Pay:

• Bonus pay

Experience:

• Manufacturing: 3 years (Required)
• Microbial: 3 years (Required)
• Trainer: 1 year (Required)

Work Location: One location