Automation CSV Consultant (DeltaV Migration/ Pharma/ Contract)

12 Months Contract Location: Tuas Up to $11,000 depending on experience Industry: Pharmaceutical

Our client aims at creating a new manufacturing concept consisting of a new generation of evolutive multi-product facilities, modular, adaptable, and agile, leveraging new disruptive technologies, to better address vaccine business challenges.

JOB PURPOSE To establish and implement a robust, risk-based and compliant validation approach for the DeltaV control system migration, ensuring timely delivery of the required validation strategy, protocols, test cases and supporting documentation. The Consultant should combine in-depth CSV expertise with practical DeltaV knowledge and effectively bridge the requirements of company Quality, Automation/Engineering and Emerson throughout the project lifecycle.

KEY ACCOUNTABILITIES Validation Strategy & Planning Develop the overall CSV/qualification strategy for the DeltaV migration. Ensure alignment with Sanofi Global Quality/CSV requirements, GxP and applicable regulatory requirements. Define the validation lifecycle, deliverables, testing approach and acceptance criteria. Prepare and maintain the Validation Plan / Validation Master Plan in line with project milestones.

Validation Documentation Prepare and/or support preparation of validation documentation, including as applicable: Computerised System Risk Assessment Design Qualification (DQ) Installation Qualification (IQ) Operational Qualification (OQ) Functional/System Qualification protocols FAT/SAT validation test cases 21 CFR Part 11 / Data Integrity assessment Requirements and test traceability Validation reports and summary documentation

Protocols shall adequately cover the DeltaV architecture, hardware/software, control functionality, alarms, batch functionality, interfaces and applicable GxP requirements. Coordination with Emerson Represent company's validation requirements in discussions with Emerson. Develop validation test cases and acceptance criteria jointly with Emerson's validation team. Review Emerson validation documentation to ensure compliance with company’s requirements. Ensure FAT/SAT activities are appropriately incorporated into the validation strategy.

Validation Execution & Closure Support FAT/SAT, IQ/OQ and other qualification activities. Provide validation guidance during test execution and resolution of deviations. Support selected test execution where required. Prepare draft validation reports and support validation closure. Ensure appropriate documentation and handover to enable Sanofi to complete activities following completion of the consultancy. The Consultant will operate as an extension of the company Project Team, representing Company's validation requirements and ensuring timely delivery of validation activities.

REQUIREMENTS: Proven CSV experience in a pharmaceutical/GxP manufacturing environment. In-depth practical experience with Emerson DeltaV DCS. Experience in control system implementation, migration or replacement projects. Hands-on experience with DQ, IQ, OQ, FAT/SAT and computerised system risk assessments. Good knowledge of 21 CFR Part 11, GxP and Data Integrity requirements. Experience working with system integrators, Emerson. Ability to translate automation/control functionality into validation requirements and test cases. Excellent technical documentation and communication skills. Ability to work independently and effectively with Engineering, Automation, Quality and project teams.

Lim Pey Chyi - Apple.lim@manpower.com.sg Recruitment Consultant (R2090579) Manpower Staffing Services (S) Pte Ltd EA Licence: 02C3423