Sr. CSV Engineer
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Job Title: Sr. CSV Engineer Location: Vacaville, CA (100% Onsite) We are currently seeking an experienced Sr. Automation CSV Engineer for an automation system migration project at Lonza, Vacaville, CA. The ideal candidate will have hands-on experience with complex PCS/MES migration projects, preferably with Rockwell and PharmaSuite platforms. Please note that this position requires the selected individual to be onsite 100% at the Vacaville, CA location. Description:10+ years of CSV/Automation experienceHands-on experience in implementation & Migration / Validation of computerized systems such as PCS (Rockwell/Client), MES (PharmaSuite, POMSnet) and SCADA/PLCsStrong, hands-on expertise with Rockwell and PharmaSuite is essentialIn-depth knowledge of SDLC, 21 CFR Part 11/Annex 11, Data Integrity, and computerized system validationAbility to work both independently and collaboratively in team environmentsExperience authoring, reviewing, approving, and executing CSV lifecycle documentationSkilled in programming, commissioning, and validating Rockwell/PharmaSuite platformsStrong understanding of 21 CFR Part 11, Annex 11, GAMP 5, and other relevant regulatory guidelinesAbility to manage, document, and assess software changes per Lonza procedures throughout the SDLCFamiliarity with S88 Batch Standard (preferred)Experience with Rockwell software object development and MES recipe authoring/testing (preferred)Experience with Kneat (preferred)Excellent verbal and written communication skills