See more Collapse

Computer System Validation Consultant

4 weeks ago

Singapore PHARMENG TECHNOLOGY PTE. LTD. Full time
Roles & Responsibilities

We 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 internationally. Our ideal candidate is a creative thinker who shares our passion for making people’s lives easier.


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 validation protocols for Computerized Equipment.
  • Generate Change requests and IT tickets tailored for report validation of Computerized Equipment.
  • Validate business intelligence reports, showcasing expertise in necessary tests for qualification.
  • Review and draft SOPs, specifically for Computer System Validation Projects, with a focus on Computerized Equipment.
  • Develop documentation for Computer System Validation projects, including URS, FRS, FRA, HLCCD, etc.
  • Address and resolve issues during Computerized Equipment validation, including deviations and change controls.
  • Ensure compliance of computerized systems, especially LabWare LIMS and other Computerized Equipment, with relevant regulations.
  • Draft templates for High-Level Risk Assessments, User Requirements Specification, Validation Plans, and Validation Summary Reports, emphasizing Computerized Equipment Validation.
  • Act as a liaison between Quality Assurance and the project team, ensuring strict compliance with regulations for GxP software and Computerized Equipment.
  • Manage planning and execution of Computerized Equipment Validation projects within established timelines and budgets.
  • Coordinate effectively with teams, clients, and stakeholders, specifically for Computerized Equipment Validation.
  • Oversee day-to-day operations of Computerized Equipment Validation projects.
  • Ensure completeness, review, approval, and proper storage of project documents related to Computerized Equipment Validation.
  • Keep the Computerized Equipment Validation team well-informed of project changes.
  • Experience with Kneat and validation of around 15 computerized systems (LCE), excluding Electrical Equipment (EE).


Required Qualifications:

  • Bachelor’s degree in business/technical field or equivalent education/experience.
  • 3 to 5 years of experience in Computer Systems Validation within the pharmaceutical/biotechnology GMP environment, involving IOQ/PQ authoring and execution, traceability matrices, and risk assessments.
  • Prior experience with Takeda and familiarity with Emerson Delta V software is a plus.
  • Strong technical skills in configuring various Laboratory systems, including Standalone instruments like Mass Spec, IC, Matersizer, UV, FTIR, DSC, etc.
  • Understanding and ability to configure TCP/IP network connectivity between systems.
  • Excellent knowledge of Desktop Operating systems, including Windows 2000, Windows 7, and Windows 10, covering permissions, user configuration, and peripheral device connections.
  • Proficient in drive mapping, logon scripts, and analyzing system logs.
  • Good understanding of Active Directory, Domain permissions, and LDAP.
  • Advanced understanding of data system security for safeguarding electronic assets, intellectual property, and privacy.
  • Experience in developing and implementing complex data exchange processes between information systems.
  • Proficient in creating/developing moderately to complex functional requirements mapping to an Information System based on user needs.
  • Ability to independently identify compliance risks and escalate when necessary.
  • Self-starter with strong team communication skills.
  • Proven ability to lead a team.

Tell employers what skills you have

FTIR
GxP
Computer Systems Validation
Windows 10
Quality Assurance
GMP
Windows 7
Electrical
Traceability
Computer System Validation
LIMS
UV
Laboratory
Windows 2000

We have other current jobs related to this field that you can find below

  • Computer System Validation Consultant

    2 weeks ago

    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...

  • Computer System Validation Engineer

    3 months ago

    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...

  • Computer System Validation Engineer

    4 weeks ago

    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...

  • Validation Consultant

    2 weeks ago

    Singapore Triton AI Pte Ltd Full time

    Perform risk-based commissioning, qualification and validation service for pharmaceutical and biopharmaceutical clients on one or more of the following areas:Process Equipment CIP / SIP Process Manufacturing and related business processes including Quality Operations and Supply Chain Operations Method validation (analytical chemistry, biochemistry,...

  • Validation Consultant

    2 weeks ago

    Singapore TRITON AI PTE. LTD. Full time

    Up to $7000 with 2 months Variable Bonus, Permanent Position:- West Singapore:- Pharmaceutical Industry Experience is a MUST:Experiences in multiple CQV discipline (such as CIP, SIP)Responsibilities: Perform riskbased commissioning, qualification and validation service for pharmaceutical and biopharmaceutical clients on one or more of the following...

  • Designer System(Computer)

    2 weeks ago

    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...

  • 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...

  • Engineering Validation

    2 weeks ago

    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...

  • Computer System Engineer

    2 weeks ago

    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...

  • Validation Manager

    2 weeks ago

    Singapore VALERE SG PTE. LTD. Full time

    Roles & ResponsibilitiesResponsibilitiesConsults with management, assesses customer requirements, and studies product characteristics to select validation objectives and standards.Prepares protocols for validation or performance testing of new or modified manufacturing equipment, processes, or systems.Analyzes data from validation tests to determine whether...

  • 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

    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...

  • 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...

  • Engineering Validation Specialist II

    1 month ago

    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...

  • Engineering Validation Specialist II

    4 weeks ago

    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...

  • Engineering Validation Specialist II

    2 weeks ago

    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...

  • Validation Engineer

    2 weeks ago

    Singapore amaris Full time

    Job descriptionAbout the jobDevelop, review and/or approve validation lifecycle documents and protocols/reports in accordance with relevant policies, standards, procedures, and guidelines, and completed in a timely fashion.Lead project validation activities and provide basic guidance and direction to junior project engineers as required.Review Turnover /...

  • Equipment Validation Engineer

    2 weeks ago

    Singapore amaris Full time

    Job descriptionAbout the jobSupports Validation activities related to validation of facility, equipment and utilities.Support day-to-day Validation activities in accordance with approved Validation SOPs/Plan/Policies.Develop & execute Validation Protocols and Reports, including supporting site discrepancies and deviations investigation/closure.Collaborate...

  • QC Validation Engineer

    2 months ago

    Singapore COALESCE MANAGEMENT CONSULTING PTE. LIMITED Full time

    Roles & ResponsibilitiesPosition: QC Validation 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.Job Description:We are currently expanding our team and are...

  • Computer Systems Administrator

    2 weeks ago

    Singapore DIPCIE CONTRACTORS PTE. LTD. Full time

    **Roles & Responsibilities: We are looking for a Computer Systems Administrator who will be in charge of our office computers, lab tops & server.Configure internal systemsDiagnose and troubleshoot technical issuesTrain new system users and set up their accountsContinuously assess the performance and effectiveness of the system.Work closely with our teams,...