The MES Engineer is responsible for driving and leading activities such as requirements gathering, authoring, testing, implementation and use of Syncade

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 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.