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Sr. Specialist, Project Leader

  • Location: Massachusetts
  • Job Type:Contract

Posted about 1 month ago

  • Expiry Date: 24 September 2022
  • Referral: 214988@accuick.com

Job Description:

  • OurCell Therapy seeks a Sr. Specialists that brings leadership, enthusiasm, intellectual curiosity, scientific rigor, and a desire to help drive novel programs.

  • The candidate must be goal-oriented, flexible, and a subject matter expert in electronic manufacturing batch records.

  • The Sr. Specialist provides input to the design and recipe development for manufacturing electronic batch records (MES).

  • The Sr. Specialist works with Digital Plant, IT, Manufacturing Operations and process subject matter experts to deliver changes to MES recipes.

  • The position requires excellent project management skills and coordination with stakeholders. The Sr. Specialist reports to the Sr. Manager Manufacturing Project Leads, Cell Therapy Manufacturing Technology.


Required Competencies:

Knowledge, Skills, and Abilities:
Education and Experience:

  • Bachelor’s degree in a related field from an accredited college or university required.

  • Minimum of 4 years relevant work experience required, preferably in the pharmaceutical, biotechnology, or cell therapy manufacturing industry.

  • Strong project 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 supporting electronic batch records, 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

Duties And Responsibilities:

  • 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.

Working Conditions:

  • The incumbent will be required to gown to access classified manufacturing areas.

  • Ability to work extended hours or a modified work schedule as required for coverage of 24/7 manufacturing operation. The position is Monday through Friday, first shift, but requires on-call availability.

  • This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

  • This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.

Contact:

Full Name: Sufiyan Sheth

Email IDsufiyans@askconsulting.com

Phone: (470)-730-2993