Computer System Validation

3 days ago

Singapore COALESCE MANAGEMENT CONSULTING PTE. LIMITED Full time
Roles & Responsibilities

Position: CSV Engineer

At Coalesce Management Consulting, we are a community of people with a strong passion for excellence. We deliver bespoke project solutions within the Life Science and Technology sectors through our community of high-calibre industry specialists.

We are currently expanding our team within our Life Sciences Division team and are looking for a CSV Engineer to support projects on site with a client. The following are key responsibilities:

  • Design, develop, and execute of CSV strategies for DeltaV systems, ensuring alignment with regulatory requirements and project timelines.
  • Collaborate with cross-functional teams (engineering, QA, IT, etc.) to define system requirements, assess functionality, and develop robust validation plans.
  • Conduct and oversee validation activities including IQ, OQ, and PQ to ensure systems meet compliance, performance, and reliability standards.
  • Perform risk assessments and impact analyses to proactively identify potential gaps, and implement appropriate mitigation strategies.
  • Prepare and maintain comprehensive validation documentation such as plans, protocols, reports, and SOPs, in line with internal standards and regulatory guidelines.
  • Provide leadership and hands-on support throughout system configuration, testing, documentation review, and deviation management.
  • Offer technical expertise in troubleshooting CSV-related issues and ensure timely resolution and continuous improvement.
  • Keep up-to-date with evolving regulatory requirements, industry standards, and innovations related to CSV and DeltaV technologies.
  • Act as the point of contact during audits and inspections, presenting documentation and validation rationale to auditors and regulatory bodies.

What's in it for you?

Our Benefits include Travel, medical Coverage, and Annual Leave options on top of your Annual base Salary as well as Training and Development Allowance inline with our values of growing by helping people grow. What's even more exciting? You get to work with World Class Teams delivering high-end Projects for the Largest Global Businesses

Coalesce Management Consulting operates as an equal opportunity employer. No terminology in this advert is intended to discriminate on the grounds of age, race, religion, sexual orientation or any other factors with no bearing to employment skills and we confirm that we are happy to accept applications from persons of any background for this role

Tell employers what skills you have
Computer Systems Validation
Management Consulting
Leadership
Troubleshooting
Computer Validation
Validation testing
Process Validation
Reliability
Protocol
Computer System Validation
Compliance
Audits
Regulatory Requirements
Life Sciences
Terminology

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