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