Computer System Validation

2 weeks ago

Singapore Coalesce Management Consulting Full time $90,000 - $120,000 per year

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

  • Computer System Validation Engineer

    2 weeks ago

    Singapore INTEGRIX SOLUTIONS PTE. LTD. Full time

    Create, review or approve validation deliverables for GMP computerized systems including but not limited to: - User Requirements Specifications - Design Reviews - Criticality assessments - Validation protocols (IQ, OQ, PQ) - Incident/deviation reports related to test protocol execution - Provide validation guidance to cross-functional teams based on...

  • Computer Systems Validation

    4 days ago

    Singapore ENFACTUM PTE. LTD. Full time

    Responsibilities Develop and implement strategies for the validation of computer systems in compliance with domestic and international regulations. Prepare and maintain all necessary validation documents, including validation master plans, validation plans, and risk assessments. Execute validation protocols and prepare validation summary reports. Manage...

  • Computer System Validation

    2 weeks ago

    Singapore COALESCE MANAGEMENT CONSULTING PTE. LIMITED Full time

    **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...

  • Computer System Validation

    2 weeks ago

    Singapore COALESCE MANAGEMENT CONSULTING PTE. LIMITED Full time

    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...

  • Junior Computer System Validation

    4 days ago

    Singapore PROCESS ENGINEERING SPECIALISTS PTE. LTD. Full time

    PES is an international services company providing Project Management, Construction Management, Commissioning & Qualification and Automation services to our clients in the pharmaceutical, nutritional and related sectors. With offices across Europe, Asia and US, our core focus is on consistently delivering high quality outcomes for our multinational clients....

  • Junior Computer System Validation

    4 hours ago

    Singapore Process Engineering Specialists Full time

    Overview Direct message the job poster from Process Engineering Specialists PES is an international services company providing Project Management, Construction Management, Commissioning & Qualification and Automation services to our clients in the pharmaceutical, nutritional and related sectors. With offices across Europe, Asia and US, our core focus is on...

  • Junior Computer System Validation

    2 weeks ago

    Singapore Process Engineering Specialists Full time

    Overview PES is an international services company providing Project Management, Construction Management, Commissioning & Qualification and Automation services to our clients in the pharmaceutical, nutritional and related sectors. With offices across Europe, Asia and US, our core focus is on consistently delivering high quality outcomes for our multinational...

  • Junior Computer System Validation

    1 week ago

    Singapore PROCESS ENGINEERING SPECIALISTS PTE. LTD. Full time

    PES is an international services company providing Project Management, Construction Management, Commissioning & Qualification and Automation services to our clients in the pharmaceutical, nutritional and related sectors. With offices across Europe, Asia and US, our core focus is on consistently delivering high quality outcomes for our multinational clients....

  • Computer System Validation

    1 week ago

    Singapore ORKA CONSULTING PARTNERS PTE. LTD. Full time $90,000 - $120,000 per year

    Key Responsibilities:Deliver consulting projects to support introduction, upgrade and maintenance of laboratory equipment with computerised system in the Life Sciences clients.Draft CQV and CSV deliverables such as URS, risk assessment, audit trail assessment, ERES assessment, IOPQ protocols, specifications and RTM.Execute CQ and CSV activities.Support...

  • Senior/Consultant (Digital Manufacturing/MES/Computer System Validation) [Pharma/Biotech]

    4 days ago

    Singapore NNIT SINGAPORE PTE. LTD. Full time

    About Us Headquartered in Denmark, NNIT Singapore Pte Ltd is a rapidly expanding leader in life science consulting, delivering innovative solutions across Singapore and the broader Asian region since 2011. We provide comprehensive, end-to-end services tailored to life science clients, covering every aspect of the value chain-from laboratory environments and...