Automation CSV Engineer - Hayward - Trinity Consultants - Advent Engineering

    Trinity Consultants - Advent Engineering
    Trinity Consultants - Advent Engineering Hayward

    7 hours ago

    Description

    Automation CSV Engineer (Biotech/Pharma)

    Location – California Bay Area

    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 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 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
    • Author, review, approve, and execute CSV lifecycle documentation, including:
    • Validation Plans
    • Risk Assessments
    • Test 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 California
    • Long-term project opportunity in a regulated manufacturing environment
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