Senior CSV Engineer – Rockwell & PharmaSuite (Onsite CA)
Trinity Consultants - Advent Engineering
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Job summary
ADVENT Engineering seeks a Sr. Automation CSV Engineer to support a complex system migration at a large regulated biotech/pharma site in the California Bay area. The role emphasizes CSV, validation, and data integrity with a focus on Rockwell and PharmaSuite environments.
You will lead CSV activities for PCS/MES migrations, author lifecycle documents, and collaborate with automation, IT, QA and manufacturing teams onsite in California. 100% onsite opportunity in a regulated manufacturing setting.
Qualifications
- 8+ years CSV/Automation in regulated biotech/pharma
- Hands-on with PCS (Rockwell/Honeywell) implementations
- Experience with MES (PharmaSuite, POMSnet) and SCADA/PLC
- Strong Rockwell and PharmaSuite expertise required
- Knowledge of SDLC, 21 CFR Part 11/Annex 11, and Data Integrity
- Excellent written and verbal communication, independently & in teams
Responsibilities
- Lead CSV and automation activities for PCS/MES migrations
- Support validation, commissioning, and migration of PCS systems
- Validate PCS (Rockwell, Honeywell) and MES (PharmaSuite, POMSnet)
- Develop/approve Validation Plans, IQ/OQ/PQ, and Traceability Matrices
- Ensure SDLC compliance and data integrity; manage software changes
- Collaborate with automation, IT, QA and manufacturing teams
Skills
Tools
Job description
ADVENT Engineering seeks a Sr. Automation CSV Engineer to support a complex system migration at a large regulated biotech/pharma site in the California Bay area. The role emphasizes CSV, validation, and data integrity with a focus on Rockwell and PharmaSuite environments.
You will lead CSV activities for PCS/MES migrations, author lifecycle documents, and collaborate with automation, IT, QA and manufacturing teams onsite in California. 100% onsite opportunity in a regulated manufacturing setting.
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