Senior Automation Validation Engineer

Senior Automation Validation Engineer Trinity Consultants
• Fremont, CA, United States

Please note:
We are only considering W2 candidates at this time. Applications from third-party vendors or C2C arrangements will not be considered.

Join ADVENT Engineering, an esteemed consulting firm dedicated to serving the pharmaceutical and biotechnology sectors. Based in the vibrant California Bay Area, with a presence across the US, Canada, and Singapore, we specialize in innovative solutions in facility design, process engineering, and quality system projects.

ADVENT offers a range of services including process optimization, automation engineering, project management, facility/system design, startup and commissioning, along with compliance consulting tailored for leading biotech and pharmaceutical manufacturing companies.

If you are an expert in automation systems and passionate about making a significant impact in the biotech/pharma landscape, we want to hear from you!

We are in search of an experienced Senior Automation Validation Engineer to spearhead a complex automation system migration project at a major, regulated biotechnology/pharmaceutical manufacturing facility in the California Bay Area. The ideal candidate will possess extensive hands‑on experience in PCS and MES system migration, validation, and implementation, with a strong preference for expertise in Rockwell and Pharma Suite environments
.

This position demands a senior engineer capable of leading CSV and automation activities independently while effectively collaborating with cross‑functional teams.

• Lead and execute CSV and automation activities for PCS/MES system migration projects
• Support the implementation, migration, commissioning, and validation of:
• PCS systems (Rockwell, Honeywell)
• MES systems (Pharma Suite, POMSnet)
• SCADA and PLC platforms
• Author, review, approve, and execute CSV lifecycle documentation, including:
• Validation Plans
• Test Protocols (IQ/OQ/PQ)
• Traceability Matrices
• Validation Summary Reports
• Ensure adherence to SDLC, 21 CFR Part 11, Annex 11, Data Integrity, and GAMP 5 standards
• Manage and document software changes throughout the SDLC in accordance with site procedures
• Support programming, configuration, commissioning, and validation of Rockwell and Pharma Suite platforms
• Collaborate effectively with automation, IT, QA, and manufacturing teams
• Assist with troubleshooting, root cause analysis, and deviation investigations as necessary
• Maintain clear communication with stakeholders at all levels

• 8+ years of experience in CSV and Automation within a regulated biotech/pharma environment
• Hands‑on experience with implementation, migration, and validation of:
• PCS (Rockwell and/or Honeywell)
• MES (Pharma Suite, POMSnet)
• SCADA/PLC systems
• Strong, hands‑on expertise with Rockwell and Pharma Suite (required)
• In-depth knowledge of:
• SDLC
• 21 CFR Part 11 / Annex 11
• Data Integrity
• Computerized System Validation (CSV)
• Able to work both independently and collaboratively within team environments
• Exceptional verbal and written communication skills

• Familiarity with S88 Batch Standard
• Experience with Rockwell software object development
• MES recipe authoring and testing experience
• Experience with Kneat

• This position requires 100% onsite support in California
• Long‑term project opportunity in a regulated manufacturing environment