Job Details

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 experience
• Hands-on experience in implementation & Migration / Validation of computerized systems such as PCS (Rockwell/Client), MES (PharmaSuite, POMSnet) and SCADA/PLCs
• Strong, hands-on expertise with Rockwell and PharmaSuite is essential
• In-depth knowledge of SDLC, 21 CFR Part 11/Annex 11, Data Integrity, and computerized system validation
• Ability to work both independently and collaboratively in team environments
• Experience authoring, reviewing, approving, and executing CSV lifecycle documentation
• Skilled in programming, commissioning, and validating Rockwell/PharmaSuite platforms
• Strong understanding of 21 CFR Part 11, Annex 11, GAMP 5, and other relevant regulatory guidelines
• Ability to manage, document, and assess software changes per Lonza procedures throughout the SDLC
• Familiarity 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