Maja Smilevska

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Syncade Engineer

Ref #: Syncade Engineer
Maja Smilevska 16/05/2023
Location: United States, New Hampshire, Hybrid Not Disclosed United States, New Hampshire, Hybrid
Salary: $125K £
Type: Permanent
Sector: Pharma | Biotec
Seniority: Mid/Senior Level
Specialisms: MES | Syncade | Manufacturing | Recipe Author
Date: 16/05/2023
Syncade Engineer

Our client are a global leader in life sciences operating, and are seeking 3 experienced MES Engineers who will be responsible for driving and leading activities such as requirements gathering, recipe authoring, testing and implementation.

This position is expected to operate 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 automation changes and 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.

Key Requirements:

  • Bachelor’s degree in science, technology, engineering or mathematics.

  • Syncade Recipe Authoring experience strongly preferred.

  • 3-7 years experience working in automation in a Pharm/Biotech environment.

  • Advanced Recipe Author (in Syncade).

  • 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.

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

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