Daniel Langley

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MES (Pas-x) Engineer

Ref #: MES (Pas-x) Engineer
Daniel Langley 25/08/2021
Location: United States, Delaware, New Jersey, Pennsylvania Not Disclosed United States, Delaware, New Jersey, Pennsylvania
Salary: $85,000 - 95,000 £
OTE: 10% bonus + RSU's
Type: Permanent
Seniority: Mid/Senior Level
Specialisms: Pas-x | MBR design from scratch | Validation of MBR's | Transition from Paper to Glass
Date: 25/08/2021
MES (Pas-x) Engineer

Our client are implementing batch records for the first time at their new state of the art facility T-Cell therapy facility in Philadelphia. This is a greenfield project and the start of a whole digitalisation journey for them starting with eBR and then will move into Automation/LIMS and other shop floor digital processes.

This 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.

The essential duties.

  • 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 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


Need more information. Give me a shout.

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