Sr. Specialist, MES

Position Overview

The Manufacturing Execution Systems (MES) Senior Specialist, 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 paper and electronic batch records creation to support engineering, clinical and commercial production at Fujifilm Diosynth Biotechnologies California (FDBC). This role will also lead and participate in 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 to ensure proper MES training is delivered to 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 document creation and review with new product introductions at FDBC.

Company Overview

Join us! FUJIFILM Diosynth Biotechnologies 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. 

Job Description

Primary Responsibilities:

• Lead and provide support in the design, development and qualification of manufacturing execution systems (MES Recipes) electronic and paper batch records.
• Support the day to day operations of the electronic batch management systems to manufacture cell therapy products.
• Collaborates with cross-functional teams to successfully deliver on New Product Introduction, re-introductions or campaign re-starts.
• Provides technical support in troubleshooting efforts for MES.
• Drives identification of continuous improvement recommendations.
• Support creation and implementation of Change Controls and CAPAs as needed.
• Support/Own investigations and QMS records as applicable.

Work Location:  Thousand Oaks, CA

Reports To:  Senior Manager, Manufacturing

Travel:  Travel possible (up to 5%)

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 5+ years of experience; or
• Bachelor of Science (B. Sc) with 7+ years of experience; or
• Associate degree with 8+ years of experience; or
• High school diploma with 9+ years of experience
• Coding certification desired

Position Requirements:

• Strong communication and time management skills (e.g. clear and concise)
• Ability to work in cross-functional team
• Project Management skills.
• Experience with MES, QMS
• Basic validation knowledge
• Working knowledge of FMEAs/risk assessments
• Advanced knowledge of processing logistics and sampling
• Advanced knowledge on technology transfer, operation and lifecycle management of cGMP clinical and commercial manufacturing processes
• Advanced knowledge of developing and delivering training programs for MES
• Advanced knowledge of material management
• Advanced knowledge of MasterData management
• Advanced knowledge of technical writing
• Experience with PAS-X and/or coding preferred

Salary and Benefits:

• $137,000 to $170,000, depending on experience
• Medical, Dental and Vision
• Life Insurance
• 401k
• Paid Time Off

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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EEO Information

Fujifilm is committed to 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 (FDBCHR@fujifilm.com).