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Sr. Specialist Cell Therapy

Devens, MA

Posted: 12/19/2022 Job Number: 22634143

Job Description

SR. SPECIALIST CELL THERAPY
DEVENS, MA
100% Onsite.

Required Skills:
  • Bachelor's degree in a related field from an accredited college or university required.
  • Minimum of 3 years relevant work experience required, preferably in the pharmaceutical, biotechnology, or cell therapy manufacturing industry.
  • Strong project management and/or change management skills are helpful.
  • Minimum of 1 year of experience with project coordination and cross-functional team leadership preferred.
  • Minimum of 1 year of experience with the execution of electronic batch records required, experience supporting electronic batch record creation and testing preferred, preferably Syncade MES.
  • Knowledge of Delta V or other process automation software desirable.
  • Ability to use process historian and analyze data to assist troubleshooting.
  • Computer System Validation (CSV) experience creating/running test scripts helpful but not required.

Project Description:
  • Apply manufacturing process expertise and electronic batch record technical knowledge to own electronic batch record changes and the associated change controls.
  • Own Electronic Batch Record (MES/Syncade) Functional specifications. Ensure consistent execution of recipe modifications and changes. Ensure adherence with governing documents related to change management.
  • Works collaboratively with Manufacturing, Digital Plant, IT, Validation, Quality, and MS&T to ensure change initiatives are driven to closure and migrated to the production area in a timely manner.
  • Owns the lifecycle of an electronic batch record change .
  • Works with site functional teams, including manufacturing, engineering, warehouse, and quality assurance to gather user requirements for recipe development.
  • Understanding of MES library objects. Use that understanding to direct changes to MES recipes and/or directly update the MES recipes utilized in Manufacturing.
  • Develop documentation to support the qualification of the MES recipes, including test scripts and functional specifications.
  • Execute testing of the recipes in the development environment to ensure functionality.
  • Manage User Acceptance Testing process for recipe qualification.
  • Provide technical support by troubleshooting and resolving MES issues to support manufacturing operations.
  • Develop and deliver reports from reporting software.
  • Able to use creative problem solving.
  • Provides technical expertise to management and less experienced professionals.
  • Perform other tasks as assigned.

This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Jim: jim@alphaconsulting.Com

ALPHA'S REQUIREMENT #22-03295
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

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Jim Pizzelanti

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