CSV Engineer

10 hours ago

Singapore GAM-X ENGINEERING SERVICES PTE. LTD. Full time $80,000 - $120,000 per year

Responsibilities:

  • Provides expertise in performing Computerized Systems Validation.
  • Primary personnel for the qualification of Computerized Systems including Automation Systems (PCS 7, EMS, MES) and GMP equipment qualifications operating within the framework of regulations GxP, 21CFR11, etc.)
  • Perform collaborative work with the Compliance Engineering team on other CQV activities.
  • Coordinate with both internal and external teams (manufacturing, engineering, quality, vendors, contractors, etc.) to achieve the site objectives.
  • Prepare, review, and approve of SOPs and qualification-related documentations (protocols and reports)
  • Ensure that the qualification strategy is sound and adhere to company standards and regulatory requirements.
  • Investigate deviations and write deviation reports and findings.
  • Raise and follow-up change control records.

Requirements:

  • Degree in Engineering/Science or related studies.
  • Minimum of 3 years to 4 years of experience in relevant industry with at least 3 years in CSV, Quality Assurance, CQV, and Turnover Activities
  • High level of understanding in Regulatory compliance
  • Primarily responsible for supporting all computer validation aspects to the automation and engineering teams. This includes Domain Controller system (DCS), Manufacturing Execution system (MES), Manufacturing data warehouse (MDW), Building Automation Systems (BAS), GMP and non-GMP, Programmable Logic Controllers (PLC) based skids, IT infrastructure, standalone computerized system with equipment and validated spreadsheet.
  • Familiar with working in a GxP environment and keeping up to date with current GxP, with flexibility to change as needed due to new regulatory requirements and technologies, as relevant for clinical and commercial supply.
  • In-depth knowledge in Computer System Validation (CSV), GAMP 5, 21 CFR Part 11, ER/ES, validation lifecycle, current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)
  • Good knowledge of GxP, GDP, CQV approaches including Validation Lifecycle approach (URS, DQ, FAT/SAT, IOQ, CSV, Cleaning/ Thermal Validation etc.), regulatory requirements and best industry practices.
  • Works 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.
  • Develop Validation Master Plans (VMP), System Level Impact Assessments, and executed FAT, SAT, and Validation Protocols (IQ, OQ, PQ).
  • Creation and/or review of validation lifecycle documents: User Requirement Specification, Functional Specification, Risk Assessments, Validation Protocols (IQ/OQ/PQ/CPV) and Reports, Study Protocols and Reports, Requirement Traceability Matrix, CFR Part 11 assessment and validation submission dossier related to CSV
  • Preferred who has training or Certification in Hardware and Fieldbus communication, Batch process Operations along with EPKS & TPS

  • CSV Engineer

    3 weeks ago

    Singapore NUSANTARA PRIME CONSULTING PTE. LTD. Full time

    Roles & ResponsibilitiesResponsibilities:Manage Computer System Validation Lifecycle from design to execution phases, Including relevant CSV documentations such as Configuration specification, design review, commissioning documents, and protocols. Work with QA and stakeholders to develop the CSV strategy Responsible for providing CSV documents and...

  • Senior Csv Engineer

    2 days ago

    Singapore PM Group Full time

    **Senior CSV Engineer**: - Contract - Onsite - Singapore, Singapore - CQV - 7316 - SGD **Overview - We have an immediate requirement for 2 - **CSV Specialists **to join a highly skilled PM Group team based on a client site. **Responsibilities **Day to day activities include the following**_:_** - Commissioning and Qualification of hardware and associated...

  • CSV Engineer

    1 week ago

    Singapore Antaes Asia Full time

    Overview Join to apply for the CSV Engineer role at Antaes Asia . 4 days ago Be among the first 25 applicants. Responsibilities Contribute to Life Science projects for Antaes Asia clients. Work with cross-functional teams in providing Quality oversight in computerized system life cycle procedures and ensure compliance with GXP standards and company policies...

  • Senior Csv Engineer

    1 week ago

    Singapore PM Group Full time

    : We have an immediate requirement for 2 **CSV Specialists **to join a highly skilled PM Group team based on a client site. : **Day to day activities include the following**_:_** - Commissioning and Qualification of hardware and associated software to support Utility/Process equipment. This includes PLC & SCADA plus interfaces with networks. - Documentation...

  • CSV Engineer

    2 days ago

    Singapore ADVANCED MANUFACTURING TECH SOLUTIONS PTE. LTD. Full time $120,000 - $180,000 per year

    We are seeking an experienced CSV Engineer to support validation of computerized systems in a GMP-regulated pharma environment. The role involves developing and executing validation deliverables, ensuring compliance with 21 CFR Part 11, Annex 11, GAMP 5 , and collaborating with cross-functional teams for successful project delivery.Key...

  • CSV Engineer

    1 week ago

    Singapore ANTAES ASIA PTE. LTD. Full time

    Job Description: Contribute to Life Science projects for Antaes Asia clients Work with cross functional team in providing Quality oversight in computerized system life cycle procedure and ensure compliance to GXP standards and company policies and procedures. Provide guidance and support to establish systems for ensuring Data integrity, compliance...

  • Csv Engineer

    2 days ago

    Singapore COMBUILDER PTE LTD Full time

    **Responsibilities**: - Lead and execute Computerized Systems Validation (CSV) activities, including planning, testing, documentation, and reporting. - Collaborate closely with the Compliance Engineering team to support commissioning, qualification, and validation (CQV) activities. - Prepare, review, and approve qualification documentation (URS, DQ, FAT,...

  • Csv Engineer

    4 days ago

    Singapore ADVANCED MANUFACTURING TECH SOLUTIONS PTE. LTD. Full time

    We are seeking a Computer System Validation (CSV) Engineer with around 5 years of relevant experience to support QC and laboratory operations in a regulated GMP environment. The role involves ensuring that computerized systems and laboratory equipment are validated, maintained, and compliant with regulatory standards, while supporting continuous improvement...

  • Csv Engineer

    2 days ago

    Singapore PSC BIOTECH PTE. LTD. Full time

    Our esteemed client is seeking highly qualified and skilled CSV Engineers, both at the Senior and Junior levels, to provide essential support for routine and project-based Computer System Validation (CSV) activities. As a CSV Engineer, you will be instrumental in ensuring the compliance, reliability, and efficiency of computer systems utilized across diverse...

  • Csv Engineer

    4 days ago

    Singapore COALESCE MANAGEMENT CONSULTING PTE. LIMITED Full time

    **Position: CQV/CSV Engineer in Singapore** **Job Description**: We are currently expanding our team and are looking for a **Computer Systems Validation Engineer **for our project on site with our client. You will be responsible for planning, writing, implementing and reviewing Computer Systems Validation protocols in place within highly regulated...