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 - [Confidential Information]

Recruitment Consultant (R2090579)

Manpower Staffing Services (S) Pte Ltd

EA Licence: 02C3423