MES Engineering Lvl 4
Lonza
- Portsmouth, NH
- Permanent
- Full-time
- Performs all work safely and meets the requisite training requirements
- Act as MES engineering lead for tech transfer of new processes into the facility
- Develop technical knowledge on manufacturing equipment and process automation systems
- Responsible for resolution of all 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 development and 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/Engineering SME
- Represents group at Engineering DMS meetings
- Participates in audits and inspections as MES SME
- Planning and execution of plant projects involving complex automation changes and significant process improvements including lump sum and CAR 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
- 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
- Approver of action plans for non-regulatory CAPA
- Participates/Leads quality risk assessments
- 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
- Assists in department recruiting efforts as an interviewer
- Mentors less experienced engineers in group
- Bachelor’s degree in science or related discipline
- Significant Biotech manufacturing/Automation experience; Prior experience of Controls/MES protocol preferred.
- Some prior knowledge of Biotech manufacturing Controls and/or MES software preferred
- Excellent Communication Skills.
- Ability to effectively communicate via writing and oral communication at all levels. Express ideas effectively in individual and group situations (including non-verbal communication).
- Ability to communicate to internal and external personnel.
- Ability to secure relevant information and identify key issues and relationships from a base of information.
- Relate and compare data from different sources and identify cause and effect relationships.
- Ability to evaluate engineering problems and be able to devise cause and effect relationships and propose solutions.