Job Location: Saint Joseph, Missouri Job Type: Full Time Department:
Other / Other Facility:
BI Vetmedica
Our Culture
In a world where business is driven by short term financial goals, Boehringer Ingelheim Corporation is truly a company with a different philosophy. Although we are one of the largest and fastest growing pharmaceutical companies in the world, we have been able to maintain a dedication to our values. Our focus is on helping patients, serving our customers and improving the quality of life for the millions of people who rely on us. Simply put, we have remained committed to doing the right thing-for our customers, our communities, our employees and everyone we serve. At Boehringer Ingelheim, we realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to create a healthy working environment-meaningful work, diversity, mobility, networking and work-life balance. Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, as well as our partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment background checks and drug screenings.
Job Description
QUALIFICATIONS:
Minimum of 5 years experience in Process instrumentation and calibration in a cGxP facility, advanced knowledge of Pharma process and utility systems
Ability to read and understand electrical schematics, P&IDs, understanding of PLC system and controls, as well as BMS and SCADA systems experience
ISA CCST minimal level 1 certification is preferred, and will be required after 18 months of employment
DUTIES & RESPONSIBILITIES:
Design, install, test, calibrate, maintain and repair assigned instrumentation within assigned time frames, and document performance through hard copy and/or electronic database entry into Calibration Management Software, following all applicable cGxP regulations and requirements
Act as the subject matter expert in assisting End Users in identifying User Requirement Specifications, assisting engineering in designing and specifying design and purchase of standalone and system based instrumentation of cGxP controls and instrumentation
Document asset history through a variety of cGxP systems, including part 11 compliant databases such as, but not limited to Datastream 7i, Procal, Trackwise, Documentum. as well as hard copy documents completed following Good Documentation Practices
Will perform cGxP System Calibration Commissioning tasks including identifying, writing, and following required procedures, building equipment/system hierarchies to insure the appropriate system history is captured, assist in initial set up and tuning of instrumentation, tagging of instrumentation, and set up in a Part 11 compliant Database
Will perform root cause failure analysis, data trend analysis, to identify causes of instrument OOT/failures, and identify effective corrective and preventive actions to limit/avoid repeated deviations
Will perform in-depth and advanced troubleshooting on autoclaves, bioreactors, fermentation systems, WFI stills, utility distribution systems, lyophillizers, Pure Steam Generators, and a variety of safety instrumentation. Will participate as a team member on various process improvement and expansion initiatives
Will identify required spare instrumentation to achieve the highest state of equipment reliability and prevent extended production downtimes. Will document and work with store room personnel to insure that adequate spares are on hand
Will provide training, supervision, set up and scheduling with contracted vendors as required to insure cost effectiveness, and compliance with internal calibration programs requirements
