Senior MES Engineer - TekWissen LLC
Portsmouth, NH
About the Job
Overview:
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 Title: Senior MES Engineer / Project Engineer
Location: Portsmouth, NH - 03801
Duration: 5 Months
Job Type: Contract
Work Type: Onsite
Summary
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 project completion
- 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
Required Skills & Qualifications
- Prior experience in supporting MSE Projects is required
- Must have experience in planning and executing changes to automation or process improvements
- Strong experience in performing change request assessments is required
- Should have experience in supporting or leading deviation investigations and root cause analyses (RCA)
- Strong hands on experience in authoring or reviewing technical documentation such as SOPs, functional specifications, or test protocols is required.
TekWissen Group is an equal opportunity employer supporting workforce diversity.
Source : TekWissen LLC