Process Engineer

Only U.S. Citizens and those authorized to work in the U.S. can be considered as W2 candidates.Process EngineerDuration: ASAP - 10/4/2022Location: Bloomington, IN 47403Support Engineer for Start-up, commissioning, and qualification of new aseptic fill line including the following equipment:•Aseptic vial filling line (open RABS) + SCADA system•Washer•Depyrogenation Tunnel•Filler•Capper (2)•Gauntlet glove Testing systemResponsibilities•Engineering support for demolition and construction (removal of old line, install new, designperformed by others)•Supports start-up, commissioning, and qualification of potential facility modifications to HVAC systems and critical utilities•Experience with Aseptic Filling startups preferred•Management of equipment OEM's, timeline, task, and closure of open issues/deviations•Review detailed design and testing documentation provided by OEM•Write Process SOPs, Forms, Job Aids, etc. for new equipment•Planning and Coordination of activities between resources, OEM resources, and Design and Construction Management Firm, and OEM validation services, including participation in ofFAT, SAT, IQ/OQ•Knowledge experience with computer system validation (21CFR Part 11) as it relates to fillingprocess equipment is preferred (integrated process equipment as opposed to enterprisesystems)•Develops into and serves as temporary subject matter expert (SME) for new equipment andsupports internal team members with process development and PQ activities•Perform gap assessments on OEM qualifications, author IQ/OQ documentation andsummaries, Equipment History Form, System and Component criticality assessments, New Instrument Calibration Forms, Electronic System Assessment Forms, PM generation, EHS Equipment Checklist•Assessment and set up of spare parts inventory•Identification, Specification and procurement of any necessary tooling and equipment tooperationalize production lines•Training of cross functional groups and development of supporting entry Level engineers into SME TimingBenefits: