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MES MBR Designer

Fremont, CA 94555

Posted: 05/29/2024 Employment Type: Contract Job Category: Scientific Job Number: 604066 Is job remote?: No Country: United States

Job Description

Target PR Range: 90-110/hr
*Depending on experience  Duties:
  • The MBR designer is responsible for understanding all the complexities of the BioMES system, revise and design new electronic batch records, troubleshoot EBR issue and lead continuous improvement initiatives relative to BioMES.
  • This position is also responsible for the overall business process and improvement topics relative to electronic records.
  • This position is expected to understand the nuances of the highly complicated electronic system.
  • This position utilizes LEAN tools to systematically evaluate information flow, create project plans and drive right first-time success.
  • The MBR designer trains modelers to learn how to generate batch records, generates and refines batch record creation training materials and troubleshoots EBRs.
  • The MBR designer works with client groups (Process Engineers, Operations, Quality) to determine design changes and improvement opportunities within the scope of electronic batch records and leads the team to prioritize and implement said improvements.
  • This role is required to work with industry experts to stay abreast of industry changes and expectations related to computer systems and electronic batch record design and to influence changes to software such that it continues to meet the needs of the business.
  • The MBR designer leads and participates in project teams and works within BioPharma BioMES team to standardize business processes.

 
Skills:
 
  • Subject matter expert relative to manufacturing and MES Master Batch Records.
  • Ability to transform/translate process information/design from process description into a MES Master Batch Record.
  • Experience working in multiple projects simultaneously.
  • Technical writing skills.
  • Technical knowledge of manufacturing systems, methods and procedures, biopharmaceutical manufacturing processes, knowledge of regulatory aspects (cGMP).
Education:
Professional training or Associates/Bachelor’s degree in STEM, IT or equivalent.
  Languages: English( Speak, Read, Write ) Minimum Degree Required: Associate's Degree (Community College, MBO)

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Fremont, CA

Join us in Fremont, California, where exciting job opportunities await! Nestled in the heart of the San Francisco Bay Area, Fremont offers a vibrant mix of culture, innovation, and natural beauty. Home to landmarks like the Niles Essanay Silent Film Museum and the Ardenwood Historic Farm, this diverse city boasts a rich arts scene, delicious cuisine, and proximity to major tech companies and Silicon Valley. With easy access to outdoor recreation at the Don Edwards National Wildlife Refuge and the Mission Peak Regional Preserve, Fremont is the perfect place to grow your career and enjoy a high quality of life. Explore our job listings today and discover the charm of Fremont!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.