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.
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