Manufacturing Execution Systems (MES) Engineer

Adaptimmune

Philadelphia, PA, US
  • Job Type: Full-Time
  • Function: Manufacturing
  • Post Date: 06/15/2021
  • Website: adaptimmune.com
  • Company Address: 351 Rouse Boulevard , Philadelphia, PA , 19112

About Adaptimmune

Adaptimmune, a leader in T-cell therapy, is a multinational, clinical-stage biopharmaceutical company focused on developing novel immunotherapies using its proprietary SPEAR T-cell receptor platform to treat solid tumors, which has the potential to transform the treatment of cancer.

Job Description

The MES Engineer will be the “Subject Matter Expert” for MES systems and processes used in Manufacturing.  They will create and maintain the electronic batch records used in GMP manufacturing. They will support manufacturing use of the MES and change control / maintenance of the electronic batch records and oversee the electronic batch record training program.

Key Responsibilities

  • Create and maintain electronic batch records, as well as related Bills of Materials (BOM’s)
  • Support the authoring of Protocols, reports and SOP’s in the document management system
  • Perform developmental testing and validation execution of Electronic Batch records
  • Maintain Electronic batch records (EBR) related Master Data in PAS-X
  • Work with QA on label requirements as it relates to electronic batch record execution
  • Support continued rollout of new studies / products including project team coordination between IT, IM, Project Management, Manufacturing, QA, warehouse, Regulatory, Legal, and IT Consultants.
  • Create / maintain training approach and related materials for PAS-X EBR execution
  • Perform end-user training of PAS-X
  • Support users performing batch record execution and perform- troubleshooting with IT as needed
  • Steward Change controls and perform impact assessments of changes associated with PAS-X as needed

Qualifications & Experience

  • BS degree in field of biochemical/chemical engineering, computer science, operations or related life science
  • Computer literate (Microsoft Suite, Word, Outlook, etc).
  • Experienced in a GMP pharmaceutical aseptic manufacturing environment
  • Working knowledge of cGMPs, and OSHA rules and regulations.
  • MBR design experience

Desirable

  • 2 years’ experience in MES Designer role in PAS-X MES
  • MES/ERP systems aptitude and experience, ideally with electronic batch records (EBR)
  • Proven ability to develop Standard Operating Procedures
  • Experience working with IT staff to define user requirements and ensure the MES system design meets business requirements EBR design in PAS-X MES or equivalent technology

 

 

At Adaptimmune we embrace diversity and equality of opportunity. We believe that the more inclusive we are, the better our work will be. We welcome applications to join our team from all qualified candidates, regardless of age, colour, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status or other legally protected category. It is our intent that all qualified applicants will receive equal consideration for employment.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.