Computerized System Validation

7 days ago


Singapore VALINA SERVICES PTE. LTD. Full time

As a CSV Engineer, you will be working for our clients in the respect of the applicable regulations and quality procedures.

Main assignments:

- To be responsible for preparing and/or executing validation activities and documentation for Computerized Systems, under respected regulations or guidelines: 21 CFR Part 11, 21 CFR Part 820, ISO 13485, GAMP 5, Annex 11, etc.
- To create and modify validation documentation, including:

- User Requirements Specifications (URS)
- Criticality analysis and Risk Analysis
- Validation Plan and Report
- Protocols, Scripts and Reports for IQ, OQ, and PQ
- Reports which summarize the results of the test executions
- Execution of qualifications scripts and reporting Validation deviations

The required professional skills and experience are:

- Degree (or similar) in IT, Engineering or Science
- 2 years’ experience working in GxP environment would be a plus, beginners are accepted and trained
- 2 years’ experience working on CSV projects would be appreciated, beginners are accepted and trained
- Excellent written/verbal English language skills are required. Other languages (French/German/Spanish) would be a plus
- Strong organizational and project management skills
- Familiar with GxP compliance requirements (FDA, EMA, GAMP 5, 21 CFR Part 11, PICs, etc.)



  • Singapore PHARMENG TECHNOLOGY PTE. LTD. Full time

    **Responsibilities**: - Create and refine validation protocols for GxP critical reports, focusing on Computerized Equipment Validation within the QC lab. - Configure static Master Data for validated/GMP-compliant LabWare LIMS (version 6), specifically emphasizing Computerized Equipment. - Actively participate in executing, reviewing, and approving...


  • 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....


  • Singapore PROCESS ENGINEERING SPECIALISTS PTE. LTD. Full time

    Roles & Responsibilities 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...


  • Singapore MATRIX PROCESS AUTOMATION PTE. LTD. Full time $40,000 - $120,000 per year

    Key Responsibilities:Develop and execute test cases, test scripts, and validation protocols (IQ, OQ, PQ) in accordance with approved procedures.Prepare validation deliverables URS, Validation Plan, Traceability Matrix, Test Summary Reports, and Deviations.Support and coordinate validation testing activities under QA oversight.Ensure all documentation and...

  • Validation engineer

    1 week ago


    Singapore GAM-X ENGINEERING SERVICES PTE. LTD. Full time $60,000 - $120,000 per year

    Responsibilities:Hands-on experience and understanding of automated systems supporting manufacturing, IT infrastructure, Engineering and operations.Strong understanding and applicable regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211, and 820 and local regulatory expectations.Promoting GMP awareness and a culture of continuous improvement...


  • 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...


  • Singapore No deviation Pte Ltd Full time

    About Nd Incorporated in 2007, we are a patient-centric solution provider for the pharmaceutical industry. We are experts in engineering consultancy, commissioning, qualification and validation services, and regulatory quality/compliance in Asia and Europe. We offer personalized focused solutions for the pharmaceutical industry in engineering consultancy...

  • CSV QA Expert

    5 hours ago


    Singapore MANPOWER STAFFING SERVICES (SINGAPORE) PTE LTD Full time

    CSV QA Expert (Pharma/ Validation/ GAMP)Salary Up to $8,000 depending on experience Location : Tuas Industry : Pharmaceutical Be part of building a next-gen, digitalized manufacturing facility in Singapore using advanced tech like AGVs, cobots, and cloud-based systems. Job Summary To ensure that computerized systems used in manufacturing and quality control...


  • Singapore Lonza Full time $80,000 - $120,000 per year

    Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...


  • Central Singapore Emprego SG Full time

    **Location** Singapore, Central Singapore **Job Type** Permanent **Salary** $6,000 - $11,500 Per Month **Date Posted** 4 hours ago Additional Details **Job ID** 94537 **Job Views** 1 **Job Description**: Roles & Responsibilities **Context** Vaccines Industrial Affaires (VIA) is preparing its future through an ambitious program named Evolutive...