Automation CSV Consultant (DeltaV Migration/ Pharma/ Contract)

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