NIRAS Hiring! Full Time DeltaV Subject Matter Expert in - Ricebowl

DeltaV Subject Matter Expert

API & Biologics Drug-Substance Manufacturing Site

Singapore

Contract/Freelance

NIRAS are a specialist engineering consultancy; focussed on the design and delivery of advanced, process engineering driven projects, providing Project Management, Engineering Design, Project and Managed Service resources to the Pharmaceutical, Brewing, Distilling, Food & Beverage Manufacturing industries across Ireland and internationally. One of Europe's largest consulting firms NIRAS employs over 3000 permanent staff and over 25,000 experts across our network including its 4 offices in Ireland and 51 offices in 32 countries across the globe.

Opportunity

Due to significant site capacity expansion to provide for increased biologic drug-substance capacity, we have an exciting opportunity for a contract / freelance DeltaV Subject Matter Expert to provide onsite support to NIRAS’s client, a major multinational pharmaceutical and biologic products manufacturer at their critical hub site in Singapore at the cutting-edge of biopharmaceutical operations within a highly dynamic cGMP environment.

This site serves as a launchpad for our client’s global pharmaceutical and biotech supply chain. This is a principle facility involved in the manufacture of raw active ingredients producing bulk biologic drug substances, utilizing cell culture, column chromatography, and ultrafiltration for complex, large-molecule medicines and small molecules and manufactured chemically synthesized APIs.

Role Overview

We 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.

What To Do Next:

If you are an energetic and ambitious DeltaV Subject Matter Expert, searching for new and exciting projects to challenge you and expand your engineering knowledge, we encourage you to apply and come join us at NIRAS.

For a confidential discussion regarding this and our many other exciting opportunities, please contact Philip Cahill at 00************* or email your cv to *************