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Open nowPosted 2 days ago

Automation CSV Consultant (DeltaV Migration/ Pharma/ Contract)

MyCareersFuture94,028 open roles

Pay
SGD 8,000 – SGD 11,000 a month
Where
Singapore
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Your applicationOpen nowAutomation CSV Consultant (DeltaV Migration/ Pharma/ Contract)MyCareersFuture · Singapore

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This job: posted 2 days ago

The posting

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 - [email protected]

Recruitment Consultant (R2090579)

Manpower Staffing Services (S) Pte Ltd

EA Licence: 02C3423

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