Clear are seeking a highly experienced, contract/freelance DeltaV Subject Matter Expert (SME) to drive process control system validation and qualification at our client’s site. In this role, you will bridge the gap between automation engineering and quality compliance. You will review code, manage VCAT audit trails, and oversee qualification protocols using the Kneat paperless execution platform to ensure compliance with global regulatory standards.
Key Responsibilities
- System Design & VCAT Management:
- Read and evaluate DeltaV code and design specifications.
- Generate and interpret DeltaV VCAT (Version Control and Audit Trail) compare reports to pinpoint exactly changes between code/database versions.
- Protocol Development & Execution:
- Author qualification protocols for DeltaV elements and PLC protocols.
- Facilitate and support post-execution reviews of executed protocols.
- Assist cross-functional teams in reviewing system risk assessments, Design Qualifications (DQ), and summary reports.
- Change Management & Testing:
- Review test events, non-conformances, and change requests arising from qualification protocols or change controls (PCM).
- Validation & Compliance Excellence:
- Ensure system compliance with cGMP, GAMP 5, and data integrity regulations.
- Utilize the Kneat platform to execute, track, and manage paperless validation workflows.
- Qualifications & Experience
- Education: Bachelor’s Degree in Computer Science, Electrical/Electronic Engineering, Automation, Chemical Engineering or related technical discipline.
- Experience: Minimum of 5+ years of hands-on experience working with Emerson DeltaV DCS within a pharmaceutical or biopharmaceutical manufacturing environment.
- Automation Skills: Proven ability to read DeltaV code, control modules, and design specifications.
- Compliance & Validation: Strong background in authoring and executing IO/OQ protocols, handling deviations, and managing change controls (PCM).
- Platform Expertise: Prior experience using Kneat for paperless qualification/validation is highly preferred.
Communication: Ability to bridge highly technical automation concepts with Quality and Operations stakeholders.
Contact urgently for more details