Daniel Langley

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MES (Syncade) Engineer III

Ref #: Syncade Engineer
Daniel Langley 05/07/2023
Location: United States, New Hampshire, Hybrid, Remote Not Disclosed United States, New Hampshire, Hybrid, Remote
Salary: Midpoint Salary $130,000 £
Type: Permanent
Seniority: Mid/Senior Level
Specialisms: MES | Syncade | Manufacturing | Recipe Author
Date: 05/07/2023
MES (Syncade) Engineer III

Our client are a global leader in Life Science Manufacturing and operate across Biologics, Small Molecules and Cell & Gene.

They're looking for 2 MES Engineers, who will be responsible for driving and leading activities such as requirements gathering, authoring, testing, implementation and use of their Syncade MES.

The position comes with a high degree of autonomy with only general supervision.

Key responsibilities:

  • Manufacturing Support
  • Develop technical knowledge on manufacturing equipment and process automation systems
  • Manage resolution of equipment breakdowns and quality issues in the suites
  • Provide SME support to Manufacturing and other departments for the design and operation of process automation equipment
  • Conduct troubleshooting and technical analyses on manufacturing equipment and process automation systems including PI data analyses, CIP/SIP circuit review, flow path analyses, code review/troubleshooting, etc.
  • Assist with tech transfer of new processes into the facility
  • Complete change request lot assessments to support lot release
  • Participates in IPT/JPT meetings and customer ad hoc meetings as MES SME
  • Represents group at MES DMS meetings
  • Participates in audits and inspections as MES SME Projects
  • Planning and execution of plant projects involving complex automation changes and significant process improvements including lump sum capital projects
  • Execute test scripts (design , execution, simulation, wet testing)
  • Own change requests and complete change request tasks to support project completion
  • Perform change request assessments Deviations / RCAs
  • Assist the Quality department with deviation investigations
  • Performs MES review/approval of deviations
  • Participate in RCAs as MES representative
  • Owns and executes completion of CAPA actions
  • Participates in quality risk assessments Documentation
  • Review/revise MES and Manufacturing related SOP’s, Functional Specifications, and work instructions as a result of CAPA, equipment/process changes, error prevention activities, etc.
  • Complete MES review/approval of batch records, deviations, commissioning protocols, and validation protocols Safety
  • Performs all work safely and meets the requisite training requirements.

Key requirements:

  • Bachelor’s degree in science, technology, engineering or mathematics.
  • Syncade Recipe Authoring experience strongly preferred.
  • Experience working in automation in a Pharm/Biotech environment.
  • Advanced Recipe Author (in Syncade).
  • Effective communication at all levels.
  • Ability to secure relevant information and identify key issues and relationships from a base of information.
  • Evaluate engineering problems and be able to devise cause and effect relationships and propose solutions.
  • Adapt to changing conditions.
  • Ability to prioritize deliverables.

To schedule with me, please use the booking link here https://calendly.com/daniel-langley

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