Senior Computer System Validation

4 weeks ago


Singapore XOT SOLUTIONS PTE. LTD. Full time
Roles & Responsibilities

Roles & Responsibilities

The Senior Computer System Validation (CSV) Engineer will be based in one of clients who is among the top tier pharmaceutical giants. The engineer will provide a wide range of support for GMP Computerized System and Data Integrity Activities at site.


Responsibilities

  • Coordinate/manage multiple small and large CSV/Data Integrity projects simultaneously
  • Execution of CSV/Data Integrity activities associated with GMP manufacturing and laboratory instruments/equipment, utilities, and facilities
  • Coordinate meetings with multiple stakeholders both internal and external, to drive project progress, deliverables discussion, facilitate decisions, capture meeting minutes/action lists, provide timely updates
  • Familiarity with ISA 88/ 95 Standards for automation system
  • Develop and review the change control proposals and drive the change management process
  • Prepare/Review System Development Life Cycle (SDLC) documents, like User Requirements Specifications (URS), Functional Design Specifications (FDS), Requirements Specifications (RS), Software Design Specifications (SDS), Detailed Design Specifications (DDS), System Architecture, Requirements Traceability Matrix (RTM), Access Matrix, Alarm Matrix
  • Prepare/Review Project Master Plan, Quality Assurance Plan (QAP), Quality Assurance Summary Report (QASR)
  • Review and approve vendor commissioning documents (FAT, SAT)
  • Prepares and execute IQ, OQ, PQ, Test Protocols, ensuring documentation meets required regulatory standards
  • Develops and update SOPs, Job Aids and Work Instructions at site
  • Develops and updates Automation training packages, and conducts Automation training
  • Provide hyper care support post system release for deviation and operation investigation
  • Work may require occasional support over shutdowns or extended hours, specifically during installation and commissioning /qualification phases
  • Perform any other duties as assigned by the Supervisor

Requirements

  • Minimum 5-7 years’ relevant working experience in pharmaceutical/Biotech industry. Candidates with less experience may be considered for the position as well.
  • Bachelor’s Degree in Life Science/Chemical/Biochemical/Electrical/Electronics/Control & Instrumentation and other engineering discipline
  • Possess excellent understanding of 21 CFR Part 11, EMA and FDA (GxP) regulations, and GAMP methodologies
  • Possess good understanding of Electrical and P&ID drawings
  • Good knowledge in commissioning and validation of DCS (DeltaV), SCADA (WinCC, FactoryTalk View, Wonderware) & PLC (Siemens, Rockwell Automation) Systems
  • Excellent written and verbal communication skills (including technical writing and presentations)
  • Possess leadership skills and be able to take initiative to lead projects/discussions, involving multiple stakeholders, departments, and varying complexity


Please drop an email to careers@xotsolutions.com if you are keen with the position and not able to apply through this web portal.


Tell employers what skills you have

DCS
FDA
Wonderware
Quality Assurance
GMP
Investigation
GAMP
Electrical
SDLC
PLC
Protocol
Biotechnology
SCADA
Computer System Validation
Change Control
Regulatory Requirements
Life Sciences
Laboratory
Manufacturing
Commissioning

  • Singapore PHARMENG TECHNOLOGY PTE. LTD. Full time

    Roles & ResponsibilitiesWe are seeking an experienced Computer System Validation Consultant to help drive our solution-based business model and take our designs to the next level. Our consultants have the chance to work hands-on with several business divisions to design, develop, test industry-leading solutions for our clients—both nationally and...


  • Singapore PHARMENG TECHNOLOGY PTE. LTD. Full time

    Roles & ResponsibilitiesWe are seeking an experienced Computer System Validation Consultant to help drive our solution-based business model and take our designs to the next level. Our consultants have the chance to work hands-on with several business divisions to design, develop, test industry-leading solutions for our clients—both nationally and...


  • 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/GMPcompliant LabWare LIMS (version 6), specifically emphasizing Computerized Equipment. Actively participate in executing, reviewing, and approving validation protocols...


  • Singapore PHARMENG TECHNOLOGY PTE. LTD. Full time

    Roles & ResponsibilitiesPharmEng 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...


  • Singapore PHARMENG TECHNOLOGY PTE. LTD. Full time

    Roles & ResponsibilitiesPharmEng 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...

  • System Validation

    3 months ago


    Singapore MOOVITA PTE. LTD. Full time

    Roles & ResponsibilitiesResponsibilities: Establish a framework for necessary contributions from various departments and facilitate their collaboration Performance testing and functional verification during system integration Carrying out validation tests, in coordination with customer representatives, during Factory Acceptance Tests (FAT) and Site...


  • Singapore Amaris Consulting Full time

    About the job Serve as a site Subject Matter Expert for at least 1 specialized validation area Planning, performance, support and coordination of Computer System Validation, Equipment validation, Sterilization In Place, cleanroom validation, Clean Utilities Validation (IQ/OQ/PQ/CPV) Maintain validation status of Computer System Validation Independently...


  • Singapore Micron Full time

    Our vision is to transform how the world uses information to enrich life for all.Join an inclusive team passionate about one thing: using their expertise in the relentless pursuit of innovation for customers and partners. The solutions we build help make everything from virtual reality experiences to breakthroughs in neural networks possible. We do it all...


  • Singapore KLA Full time

    Company OverviewKLA is a global leader in diversified electronics for the semiconductor manufacturing ecosystem. Virtually every electronic device in the world is produced using our technologies. No laptop, smartphone, wearable device, voice-controlled gadget, flexible screen, VR device or smart car would have made it into your hands without us. KLA invents...


  • Singapore Marvell Full time

    About MarvellAt Marvell, we believe that infrastructure powers progress. That execution is as essential as innovation. That better collaboration builds better technology. Trusted by the world's leading technology companies for 25 years, we move, store, process and secure the world's data with semiconductor solutions designed for our customers' current needs...


  • Singapore SVENTL ASIA PACIFIC PTE. LTD. Full time

    Roles & ResponsibilitiesResponsibilities/Job Scope:• Pre-silicon verification and post-silicon system validation• Test case and test automation scripts development and test plan execution• Debug system (hardware, software and firmware), provide expert support to internal as well as external customer• Silicon characterization and failure analysis•...


  • Singapore ESCO ASTER PTE. LTD. Full time

    Roles & ResponsibilitiesThe OpportunityEsco Lifesciences Group, is Singapore’s most globalized life sciences company, with annual revenues close to SGD 200M and global operations in over 20 countries across North America, Europe and Asia.Esco Aster Pte Ltd is an affiliate of Esco Lifesciences Group and was first introduced in 2017.At Esco Aster Pte Ltd, we...


  • Singapore ESCO ASTER PTE. LTD. Full time

    Roles & ResponsibilitiesThe OpportunityEsco Lifesciences Group, is Singapore’s most globalized life sciences company, with annual revenues close to SGD 200M and global operations in over 20 countries across North America, Europe and Asia.Esco Aster Pte Ltd is an affiliate of Esco Lifesciences Group and was first introduced in 2017.At Esco Aster Pte Ltd, we...

  • Validation Engineer

    1 month ago


    Singapore ONE STOP ENGINEERING PTE. LTD. Full time

    Roles & ResponsibilitiesValidation engineers manage, inspect, calibrate, test and modify the instrumentation, equipment, mechanics and procedures used in manufacturing. A critical aspect of their job is documenting this process so there is evidence that systems are operating safely and efficiently.Validation engineers can be found in a range of industries,...

  • Validation Engineer

    2 months ago


    Singapore MIKRON SINGAPORE PTE. LTD. Full time

    Roles & ResponsibilitiesMain Responsibilities:1. Assist Quality and Validation Manager Asia to complete the tasks in time with good quality.2. Responsible for successful execution the Validation functions for customer project, as required – Quality, Cost, Time.3. Responsible to drive and support project team for projects where validation is required and...

  • Validation Engineer

    4 weeks ago


    Singapore MIKRON SINGAPORE PTE. LTD. Full time

    Roles & ResponsibilitiesMain Responsibilities:1. Assist Quality and Validation Manager Asia to complete the tasks in time with good quality.2. Responsible for successful execution the Validation functions for customer project, as required – Quality, Cost, Time.3. Responsible to drive and support project team for projects where validation is required and...


  • Singapore Takeda Pharmaceutical Full time

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job...


  • Singapore Takeda Pharmaceutical Full time

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job...


  • Singapore Takeda Pharmaceutical Full time

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job...


  • Singapore MITRAA AGENCIES PTE. LTD. Full time

    Minimum Bachelor's degree. Minimum 3 years relevant working expereince. Have to work for peak hours and weekends, the public holiday also.- a computer designer starts with a client consultation. These discussions allow them to understand how the company's business goals correlate with their technological needs. After the consultation the computer designer's...