Senior CSV Automation Engineer – Rockwell/PharmaSuite (Bend, OR)

Energy Jobline ZR; Bend (OR); On-site; USD 120,000 - 180,000; Full time

Job summary

ADVENT Engineering is seeking a Sr. Automation CSV Engineer to support a complex CS/CV migration project at a large biotech/pharma site. The role demands hands-on expertise in Rockwell and PharmaSuite with extensive SDLC and 21 CFR Part 11 work, data integrity, and proven collaboration across cross-functional teams.

100% onsite in Bend, OR with Bay Area travel. The candidate will independently lead CSV activities, validate MC/PCS migrations, and ensure strict adherence to regulatory standards

Qualifications

• 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) and MES (PharmaSuite, POMSnet).
• Experience with SCADA/PLC systems.
• Strong, hands-on expertise with Rockwell and PharmaSuite (required).
• In-depth knowledge of SDLC, 21 CFR Part 11 / Annex 11, Data Integrity, and CSV.

Responsibilities

• Lead and execute CSV and automation activities for PCS/MES system migration projects.
• Support implementation, migration, commissioning, and validation of PCS systems (Rockwell, Honeywell), MES systems (PharmaSuite, POMSnet), SCADA/PLC platforms (FactoryTalk).
• Author, review, approve, and execute CSV lifecycle documentation (Validation Plans, Risk Assessments, Test Protocols, Traceability Matrices, Validation Summary Reports).
• Ensure compliance with SDLC, 21 CFR Part 11, Annex 11, Data Integrity, and GAMP 5.
• Manage and document software changes throughout the SDLC per site procedures.
• Support programming, configuration, commissioning, and validation of Rockwell and PharmaSuite platforms.
• Collaborate with automation, IT, QA, and manufacturing teams.
• Support troubleshooting, root cause analysis, and deviation investigations as needed.
• Communicate effectively with stakeholders at all levels.

Skills

Senior engineer

CSV execution

Automation engineering

Documentation

Tools

Rockwell

PharmaSuite

POMSnet

FactoryTalk

Kneat

Honeywell

Job description

ADVENT Engineering is seeking a Sr. Automation CSV Engineer to support a complex CS/CV migration project at a large biotech/pharma site. The role demands hands-on expertise in Rockwell and PharmaSuite with extensive SDLC and 21 CFR Part 11 work, data integrity, and proven collaboration across cross-functional teams.

100% onsite in Bend, OR with Bay Area travel. The candidate will independently lead CSV activities, validate MC/PCS migrations, and ensure strict adherence to regulatory standards