Manufacturing Specialist Manufacturing Specialist MES
Manufacturing Specialist Manufacturing Specialist MES
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$ 115000 - 143000
1 Vacancy
Job Description
Position Overview
The work we do at FUJIFILM Diosynth Biotechnologies (FDB) changes lives and our united passion for advancing tomorrows medicines our Genki will always be our driving force. While working as a Manufacturing Specialist MES with our Thousand Oaks team youll be joining other motivated individuals who fuel one anothers 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.
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
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 systems (MES Recipes).
- Technical SME on manufacturing processes.
- Support the daytoday 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 highquality 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:
- $115000 to $143000 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:
Unclear Seniority
Employment Type
Unclear
