TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps their customers to deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, Bioscience, Biopharmaceuticals, Custom manufacturing, Biotechnology, Life science ingredients, Nutrition, Microbial Control, Agriculture, Materials Science, Personal Care, and cell and gene therapy.
Job Description:
MES Engineer is responsible for supporting activities such as requirements gathering, testing, implementation and use of Manufacturing Execution Systems (MES). Position is expected to operate with some supervision and some autonomy.
Safety
Performs all work safely and meets the requisite training requirements
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 equipment.
Conduct troubleshooting and technical analyses on manufacturing equipment and process control 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 as MES representative
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 projectcompletion
Perform change request assessments
Deviations / RCAs
Assist the Quality department with deviation investigations
Participate in RCAs as MES representative
Assist with completion of CAPA actions
Participates in quality risk assessments
Documentation
Review/revise automation 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
Author and review test protocols
TekWissen® Group is an equal opportunity employer supporting workforce diversity.