Preferred: 8+ years of pharmaceutical industry experience in an engineering role (5+ years with CIP)
Primary Skills
· Support CIP troubleshooting efforts as a subject matter expert (SME)
· Support commissioning, qualification, and validation (CQV) team activities (reviewing protocols, reviewing SOPs, contacting vendors for information, equipment troubleshooting, etc.)
· Drive resolution of CQV testing issues and findings (organize meetings, generate technical justifications, etc.)
· Monitor system punch list and drive punches to closure
· Maintain highlighted CIP flow path drawings
· Support investigations associated with instrument out of tolerance events
· Generate Trackwise change controls and drive them to closure
· Generate preventative maintenance (PM) plans
· Identify spare parts based on vendor documentation
Preferred (but not required skills)
· DeltaV troubleshooting skills (need to be able to direct the automation team to what needs to be fixed / changed)
· Washer and/or autoclave experience
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