Automation CSV Engineer

Automation CSV Engineer (Biotech/Pharma)Location – California Bay AreaPlease 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 companies.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 OverviewWe 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 ResponsibilitiesLead and execute CSV and automation activities for PCS/MES system migration projectsSupport implementation, migration, commissioning, and validation of:PCS systems (Rockwell, Honeywell)MES systems (PharmaSuite, POMSnet)SCADA and PLC platformsAuthor, review, approve, and execute CSV lifecycle documentation, including:Validation PlansRisk AssessmentsTest Protocols (IQ/OQ/PQ)Traceability MatricesValidation Summary ReportsEnsure compliance with SDLC, 21 CFR Part 11, Annex 11, Data Integrity, and GAMP 5Manage and document software changes throughout the SDLC per site proceduresSupport programming, configuration, commissioning, and validation of Rockwell and PharmaSuite platformsCollaborate with automation, IT, QA, and manufacturing teamsSupport troubleshooting, root cause analysis, and deviation investigations as neededCommunicate effectively with stakeholders at all levelsRequired Qualifications8+ years of experience in CSV and Automation within a regulated biotech/pharma environmentHands-on experience with implementation, migration, and validation of:PCS (Rockwell and/or Honeywell)MES (PharmaSuite, POMSnet)SCADA/PLC systemsStrong, hands-on expertise with Rockwell and PharmaSuite (required)In-depth knowledge of:SDLC21 CFR Part 11 / Annex 11Data IntegrityComputerized System Validation (CSV)Ability to work independently and collaboratively in team environmentsExcellent verbal and written communication skillsPreferred QualificationsFamiliarity with S88 Batch StandardExperience with Rockwell software object developmentMES recipe authoring and testing experienceExperience with KneatAdditional InformationThis position requires 100% onsite support in CaliforniaLong-term project opportunity in a regulated manufacturing environment