Manufacturing Specialist, Manufacturing Execution Specialist (MES) at FUJIFILM Holdings America Corporation

The work we do at FUJIFILM Diosynth Biotechnologies (FDB) changes lives, and our united passion for advancing tomorrow's medicines - our Genki - will always be our driving force.  While working as a Manufacturing Specialist, MES with our Thousand Oaks team, you'll be joining other motivated individuals who fuel one another's passions and embrace every day as an opportunity.  We am to foster a collaborative, innovative and rewarding environment, where diverse perspectives and people come together united by a common purpose and shared values.  We pursue our fullest potential as individual contributors and team members.  We strive to be the employer of choice and offer a competitive compensation and benefit package.

External US

The Manufacturing Specialist, Manufacturing Execution Systems (MES) will provide technical input and day-to-day support for MES on and off the manufacturing floor. This role will support the manufacturing team in the implementation and operation of the electronic batch records, including engineering, start-up, commissioning, and qualification to support manufacturing at Fujifilm Diosynth Biotechnologies California (FDBC). This role will also lead and participate in paper and manufacturing batch record recipe design and will be responsible for coordinating activities with IT and QA to ensure successful implementation of batch record changes. The candidate will work with manufacturing supervisors to ensure proper training of the automated systems is provided to all manufacturing floor staff. The candidate will provide both EBR and process support to the manufacturing team during operations. In addition, the candidate will participate in batch record and document creation with new product introductions at FDBC.

Work Location: Thousand Oaks, CA

Reports to: Senior Manager, Manufacturing

Travel: Travel possible (up to 5%).

Primary Responsibilities:

• Lead and provide support in the design, development, and qualification of manufacturing execution systems (MES Recipes).
• Technical SME on manufacturing processes.
• Support the day-to-day operations of the electronic batch management systems, including recipe development to manufacture cell therapy products.
• Support in batch record and document creation with new product introductions at FDBC.
• Collaborates with manufacturing quality partner and internal quality teams to develop processes and systems that enable compliant, successful technology transfers, operation and lifecycle management of cGMP clinical and commercial manufacturing processes, ensuring all product delivery schedules are met.
• Works closely with the Manufacturing leadership team to ensure alignment and established priorities to meet and exceed site and corporate goals.
• Provides technical depth to support troubleshooting efforts for MES.
• Drives timely decisions and facilitates active communication and information flow.
• Works collaboratively and transparently with Quality Assurance to ensure a high-quality level of cGMP produced manufacturing excellence.

Physical Requirements: Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office, manufacturing plant or clinical environment.

Education and Professional Experience:

• Master of Science (M.Sc.) with 3+ years of experience; or
• Bachelor of Science (B.Sc.) with 5+ years of experience; or
• Associate degree with 6+ years of experience; or
• High school diploma with 7+ years of experience
• Coding certification desired

Position Requirements:

• Strong communication skills (e.g., clear and concise), team player
• Experience with MES, QMS, SAP.
• Demonstrated experience working through multiple simultaneous projects.
• Working knowledge of FMEAs / risk assessments
• Working knowledge of processing logistics and sampling
• Working knowledge on technology transfer, operation and lifecycle management of cGMP clinical and commercial manufacturing processes
• Working knowledge of developing and delivering training programs for MES
• Working knowledge of material management
• Working knowledge of MasterData management
• Working knowledge of technical writing

Salary and Benefits:

• $115,000 to $143,000, depending on experience
• Medical, Dental and Vision
• Life Insurance
• 401k
• Paid Time Off

Join us! FDB is advancing tomorrow’s medicine, impassioning employees to chase the impossible and continually expand their potential. We are a company of emboldened goal seekers – driven by an innate desire to better ourselves, our families, our workplace, our company, our community and the world at large.

FDBC is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, religious creed, sex (includes pregnancy, childbirth, breastfeeding, and related medical conditions), and sexual orientation and any other status protected by state or federal law.

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.