Digital Manufacturing and Computer System Validation Specialist

5 days ago

Singapore beBeeCareer Full time
Life Sciences Consultant

Job Overview

NNIT is seeking experienced professionals from the life sciences industry for a full-time on-site role at client locations in Singapore. As a Senior/Consultant in Digital Manufacturing, Computer System Validation (CSV), you will be supporting clients through the entire project lifecycle in ensuring all computer systems and software applications are validated according to industry standards, regulatory, and client requirements.

You will report to your Line Manager and work closely with key stakeholders on-site. Your expertise and proactive approach will be crucial in driving project success and delivering high-quality service.

Key Responsibilities:

  • Perform qualification/validation activities such as IQ, OQ, PQ, and ensure systems meet predefined requirements.
  • Ensure compliance in system validation processes by following FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and other global regulations.

Required Skills and Qualifications

  • Experience: Over 3 years in a pharmaceutical or GMP environment, with expertise in either GxP Computer Systems Validation, Manufacturing Execution Systems (MES), or Data Management technologies.
  • Education: At least a Bachelor's degree in Engineering or Science.
  • Regulatory Knowledge: Familiarity with FDA 21 CFR Part 11, EU Annex 11, GAMP 5, and other global regulations.

Benefits of Joining Our Team

  • Impactful Projects: Consulting roles with international healthcare clients on strategically significant projects.
  • Professional Environment: Work within a motivated team in a professional consultancy setting.
  • Leadership Opportunities: Take on leadership roles and contribute to shaping our organization.
  • Career Development: Excellent opportunities for career advancement within a leading consulting firm.
  • Training & Mentoring: Structured training programs and peer mentoring to support your professional growth.

We Invite You to Apply for This Opportunity
Tell employers what skills you have
Computer Systems Validation
Pharmaceutical Industry
Validation
Troubleshooting
FDA
OSI
Change Management
Data Management
GAMP
Information Technology
Manufacturing Operations
Change Control
Life Sciences
Laboratory
Manufacturing Execution Systems
Incident Management

  • Digital Manufacturing and Computer System Validation Specialist

    1 week ago

    Singapore beBeeCareer Full time $120,000 - $160,000

    Life Sciences ConsultantJob OverviewNNIT is seeking experienced professionals from the life sciences industry for a full-time on-site role at client locations in Singapore. As a Senior/Consultant in Digital Manufacturing, Computer System Validation (CSV), you will be supporting clients through the entire project lifecycle in ensuring all computer systems and...

  • Validating Computer Systems Specialist

    1 week ago

    Singapore beBeeValidation Full time $80,000 - $120,000

    Computer System Validation (CSV) Engineer PositionWe are seeking a skilled Computer System Validation (CSV) Engineer to support QC and laboratory operations in a regulated environment.Main ResponsibilitiesValidate QC systems such as LIMS, Empower, CDS, and other analytical equipment.Author and execute CSV deliverables including URS, Risk Assessments,...

  • Computer System Validation Specialist

    7 days ago

    Singapore beBeesystem Full time $80,000 - $120,000

    Job TitleWe are seeking a Computer System Validation (CSV) Engineer with around 5 years of relevant experience to support quality control and laboratory operations in a regulated Good Manufacturing Practices (GMP) environment.

  • Computer Systems Validation

    5 days ago

    Singapore PM ASIA PROJECT SERVICES PTE. LTD. Full time

    Roles & ResponsibilitiesResponsibilitiesWork with Engineers to develop Computer Validation Strategy, plans, protocols, reports, risk assessment, requirement traceability matrix etc for any new or change induced validation system / activities. Schedule, organize and coordinate at detailed site level, validation activities with cross functional groups Assist...

  • 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 Specialist

    5 days ago

    Singapore beBeeCompliance Full time $96,000 - $128,000

    Job Title: Computer Systems Validation Specialist Develop and implement comprehensive validation strategies to ensure compliance with domestic and international regulations, including GxP, GAMP5, ERES, and Data Integrity.Prepare and maintain all necessary validation documents, such as validation master plans, validation plans, and risk assessments, ensuring...

  • Computer System Validation Engineer

    7 days ago

    Singapore beBeeComputer Full time $90,000 - $120,000

    Validation Specialist Job DescriptionThis role involves ensuring the quality of computerized systems, particularly in areas related to Good Manufacturing Practices (GMP). The ideal candidate will have strong analytical skills and experience working with cross-functional teams.Responsibilities:Provide Quality oversight in computerized system life cycle...

  • Computer System Validation

    2 weeks ago

    Singapore COALESCE MANAGEMENT CONSULTING PTE. LIMITED Full time

    Roles & ResponsibilitiesPosition: CSV EngineerAt 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...

  • Computer System Validation

    4 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...

  • Computer System Validation Engineer

    1 day ago

    Singapore PHARMENG TECHNOLOGY PTE. LTD. Full time

    PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997. Our specialists hold expertise in Commissioning & Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective...