Manufacturing Coordinator – Upstream, Changeover

We are ‘Advancing tomorrow’s medicines’ and making a real difference to the world in which we live. At Fujifilm Diosynth Biotechnologies, we partner with our clients to deliver recombinant proteins, viral vaccines and gene therapies to patients. As a Contract Development & Manufacturing Organization (CDMO), our focus is to combine technical leadership in cell culture, microbial fermentation and viral vectors with world class GMP manufacturing facilities to advance tomorrow’s medicines. We seek candidates with proven ability to work independently and collaboratively to achieve optimized strategies, and execution programs with the ultimate goal of delivering products that transform the lives of patients.

The Manufacturing Group is seeking a highly motivated individual to be responsible for activities associated with the authoring and ownership of deviations, change control and change over from a technical aspect, and acts as a management representative manufacturing systems. Complete support for the right first time execution of manufacturing per locked schedule and support of the timely release and disposition of batches.

Major Activities and Responsibilities

Main areas of responsibilities include:

Compliance-

  • Leads deviation resolution and closure with subject matter expert and quality teams.
  • Generate Quest Data and report metrics and trends. Manage PRs with to zero overdue metrics and drive interim impact assessments, when required.
  • Responsible for tracking CAPAs to closure.
  • Author and Reviewer of SOPs and Work Instructions.
  • Responsible for Periodic Updates of SOPs and Work Instructions.
  • Ensuring tier boards are updated with metrics related to deviations, CAPAs
  • Participating in routine practices and team projects relating to TPM, 5S, Lean Six Sigma, Change Control, Safety, Quality, etc.
  • Interaction with groups such as Materials Management, EHS, Quality Control and Quality Assurance (QA) on any issues that may arise during the shift or record review.

Equipment and Room Coordinator

  • Opens and completes change order records and coordinates sampling supplies and sampling execution
  • Maintenance POC/Attends Weekly Maintenance Schedule Meeting
  • Ensuring tier boards are updated with metrics related to Change Controls, Change Overs and Equipment Status.
  • Participating in routine practices and team projects relating to TPM, 5S, Lean Six Sigma, Change Control, Safety, Quality, etc.
  • Interaction with groups such as Materials Management, EHS, Quality Control and Quality Assurance (QA) on any issues that may arise during the shift or record review.
  • System owners, responsible for continuous improvement in areas assigned by management including equipment tracking and offsite storage coordination (equipment transfer to and from) and others.
  • Assist in the coordination of outside resources, for example support of water runs and critical activities, media run, qualifications or requalification to ensure readiness.

Facility and Operation Coordinator

  • Oversight of Suite Cleaning Staff, ensuring schedule and compliance
  • Updating batch records, coordinating supplemental sample plans
  • Hosts manufacturing Tours for clients, audits, corporate visitors
  • Participating in routine practices and team projects relating to TPM, 5S, Lean Six Sigma, Change Control, Safety, Quality, etc.
  • Interaction with groups such as Materials Management, EHS, Quality Control and Quality Assurance (QA) on any issues that may arise during the shift or record review.
  • System owners, responsible for continuous improvement in areas assigned by management including gowning, material and equipment transfer, facility cleaning and adverse trend monitoring
  • Troubleshooting quality defects and making any process changes necessary to eliminate the defects; recording corrective and preventative actions

BACKGROUND REQUIREMENTS:

Preferred Education, Experience and Skills – Minimum Requirements:

  • BS/BA (science preferred) and 3+ years of experience in a cGMP (pharmaceutical/manufacturing environment or
  • AA (science preferred) and 5+ years of experience in a cGMP (pharmaceutical/manufacturing) environment

FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, as may be amended. To conform to these laws and regulations, applicants must be U.S. citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S. Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company’s ability to secure an export authorization. FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.

FDBU is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.

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