Automation Validation Pharma Specialist
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Engagement Overview:
Primary work location = Keene, NH. Occasional travel to Cambridge, Ontario and Southington, CT will be required.
Workload:
o Two manufacturing equipment systems in development for Southington, CT facility.
Supported by Keene personnel.
High speed automation line from supplier in Canada.
Industrial batch washing/siliconization system from supplier in Italy.
o Automation equipment being transferred from Keene.
~ 15 high output automation assembly lines.
o Production support to Keene Operations team.
Responsibilities:
Support design reviews, debug, acceptance and validation activities for equipment being developed by external suppliers.
Support decommissioning of equipment at Keene site and recommissioning at Southington site.
Support Keene production as needed.
Estimated duration: 6 to 9 months
Candidate level:
Engineer at E2, E3 or Senior. Open to principal level.
Qualifications:
4+ years experience in a medical device manufacturing environment.
Validation experience: IQ, OQ, PQ and TMVs.
Automation control systems background PLCs, HMI, Servos & Robots.
Familiarity with standard MS Office tools.
Good verbal and written communication skills.
Additional desired qualifications not mandatory:
Fundamental knowledge of statistical analysis - specifically GR&Rs & Process Capability.
Allen-Bradley programming experience.