Sr Specialist MES
Sr Specialist MES
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$ 137000 - 170000
1 Vacancy
Job Description
Position Overview
The Manufacturing Systems (MES) Senior Specialist will provide technical input and daytoday 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 tomorrows 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 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 crossfunctional teams to successfully deliver on New Product Introduction reintroductions or campaign restarts.
- 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 crossfunctional 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 PASX and/or coding preferred
Salary and Benefits:
- $137000 to $170000 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 viaemail 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 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 preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department .
Required Experience:
Senior IC
Employment Type
Unclear
