Job Description

Automation CSV Engineer (Biotech/Pharma)

Location – Bend, OR with travel to California

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

ADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Headquartered near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, our company is involved in almost every facet of global pharmaceutical and biotechnology facility design and process engineering and quality system projects.

ADVENT's services include process engineering, automation engineering, project engineering, facility/system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing compani

es.The successful candidate will work with a group of engineers involved in the design, automation, commissioning and start-up of various processes, systems and facilities. A combination of strong technical aptitude, automation engineering skills and technical writing are the desired skill set.

This is an outstanding opportunity to join our growing team!

Position Overview

We are seeking an experienced Sr. Automation CSV Engineer to support a complex automation system migration project at a large, regulated biotechnology/pharmaceutical manufacturing site in the California Bay area. The ideal candidate will bring deep, hands-on expertise in PCS and MES system migration, validation, and implementation, with a strong preference for experience in Rockwell and PharmaSuite environments.

This role requires a senior-level engineer capable of independently executing and leading CSV and automation activities while collaborating closely with cross-functional teams.

Key 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 and PLC platforms (FactoryTalk)Author, review, approve, and execute CSV lifecycle documentation, including: Validation PlansRisk AssessmentsTest Protocols (IQ/OQ/PQ)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

Required 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)
MES (PharmaSuite, POMSnet)
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
Computerized System Validation (CSV)
Ability to work independently and collaboratively in team environments
Excellent verbal and written communication skills

Preferred Qualifications

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

Additional Information

This position requires 100% onsite support in Bend, OR
Travel to the Bay area

Trinity Consultants - Advent Engineering

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Automation CSV Engineer