Validation Specialist

4 weeks ago


Singapore ANTAES ASIA PTE. LTD. Full time
Roles & Responsibilities

Job Description:

  • Contribute to Life Science projects for Antaes Asia clients
  • Manage change control processes for computer systems, ensuring accurate documentation, risk assessment, and approval workflow.
  • Coordinate with relevant departments to assess the impact of changes and ensure successful integration into existing systems.
  • Support Corrective and Preventive Actions (CAPA) for computer systems, conducting root cause analysis and implementing effective solutions.
  • Utilize and manage TrackWise for quality management processes, including deviations, CAPAs, and change control tracking.
  • Develop and configure TrackWise workflows and ensure proper documentation.
  • Develop and execute validation test scripts for Kneat to verify functionality, performance, and regulatory compliance.
  • Document test results, deviations, and corrective actions, and ensure alignment with validation protocols.
  • Contribute to the promotion of Antaes services on top of assistance provided to clients

Job Requirements:

  • Bachelor’s degree in Computer Science, Life Science, or a related field
  • 1-2 years of experience in validation of computer system in the pharmaceutical industry
  • Proficiency in Kneat, TrackWise, CAPA, and change control processes.
  • Familiarity with industry regulations (e.g., FDA 21 CFR Part 11, GAMP 5).
  • Ensure compliance with 21 CFR Part 11 and other relevant data integrity regulations.
  • Strong documentation and technical writing skills.
  • Candidate must be highly motivated, be able to work independently as well as in a team and have good organizational and oral and written communication skills
  • Excellent communication skills, both written and verbal, in English

Tell employers what skills you have

Excellent Communication Skills
Pharmaceutical Industry
CAPA
FDA
Risk Assessment
Regulatory Compliance
Quality Management
Technical Writing
Quality System
GAMP
Equipment Qualification
Change Control
Prevention
Manage Change

  • Singapore Amaris Consulting Full time

    Job Title: CSV Validation SpecialistJob Summary:Amaris Consulting is seeking a skilled CSV Validation Specialist to join our team. The ideal candidate will have a strong background in computer systems validation within the pharmaceutical industry.Key Responsibilities:Develop and implement CSV strategy and validation plans for computerized systems.Create and...

  • Validation Specialist

    4 weeks ago


    Singapore RECRUIT EXPRESS PTE LTD Full time

    Job SummaryA highly skilled Validation Specialist is needed to join our team at Recruit Express Pte Ltd. The successful candidate will be responsible for ensuring the validation and qualification of equipment, processes, and facilities in a cGMP manufacturing environment. This role requires a strong understanding of quality regulations and standards,...


  • Singapore Amaris Consulting Full time

    Job Description:Amaris Consulting is seeking a highly skilled CSV Validation Specialist to join our team. As a CSV Validation Specialist, you will be responsible for developing and implementing CSV strategies and validation plans for computerized systems, including LIMS, MES, eBR, and other relevant software.Key Responsibilities:Validation Planning: Develop...


  • Singapore NUSANTARA PRIME CONSULTING PTE. LTD. Full time

    Job Summary:As a CSV Validation Specialist at NUSANTARA PRIME CONSULTING PTE. LTD., you will be responsible for managing the Computer System Validation Lifecycle from design to execution phases. This includes creating and executing validation documents, protocols, and test cases using valgenesis software. You will work closely with Subject Matter Experts...


  • Singapore Amaris Consulting Full time

    Amaris Consulting is seeking a skilled Validation Engineer to join our team. As a Senior Validation Specialist, you will play a crucial role in ensuring the accuracy and compliance of our computerized systems.Job Summary:We are looking for a highly experienced professional with around 3-7 years of experience in computer systems validation (CSV) engineering....


  • Singapore Wood Full time

    At Wood, we are seeking a highly skilled Pharmaceutical Validation Specialist to join our team. This role is responsible for ensuring that our pharmaceutical manufacturing processes, equipment, and systems comply with regulatory requirements, industry standards, and company policies.Key Responsibilities:Develop and implement validation plans for laboratory...


  • Singapore NES GLOBAL PTE. LTD. Full time

    Role OverviewNES Global PTE. LTD. is seeking a Manufacturing Validation Specialist to join their team in Singapore.Job SummaryThis is an exciting opportunity for a highly skilled and motivated individual to work on validating equipment and ensuring compliance with safety and quality standards in the pharmaceutical industry.Responsibilities:Develop,...


  • Singapore Amaris Consulting Full time

    Job Title: Senior System Validation SpecialistAmaris Consulting is a leading provider of consulting services in the pharmaceutical and biotech industries.Estimated Salary: $120,000 - $180,000 per yearAbout the Role:We are seeking an experienced Senior System Validation Specialist to join our team. The ideal candidate will have a strong background in system...


  • Singapore Snaphunt Full time

    About the RoleWe are seeking a highly skilled Process Validation Specialist to join our team at Snaphunt. As a Process Validation Specialist, you will be responsible for ensuring the safety and purity of products by validating processes in accordance with GMP and cGMP regulations.ResponsibilitiesLead cleaning validation efforts to ensure robust and...


  • Singapore NNIT Full time

    Job Overview:We are seeking a skilled Technical Validation Specialist to join our team at NNIT. This role will involve providing Computerized System Validation (CSV) consulting services to pharmaceutical and medical device manufacturing clients.Estimated Salary: $90,000 - $120,000 per yearAbout the Role:In this position, you will be responsible for managing...

  • Validation Specialist

    3 weeks ago


    Singapore QUASAR MEDICAL (SINGAPORE) PTE. LTD. Full time

    Job Summary:The Validation Engineer plays a pivotal role in ensuring the quality of medical devices and manufacturing processes. The position is responsible for leading and executing validation activities, including equipment, process, and software validation. This ensures that products are manufactured consistently and reliably in accordance with Good...


  • Singapore OCBC Bank Full time

    OCBC Bank, one of Singapore's longest established banks, is seeking a skilled Model Validation Specialist to join its Market Risk Management team. This permanent, full-time role offers a competitive base salary and a range of benefits to support your career and wellbeing.About the RoleThe Model Validation Specialist will be responsible for validating pricing...


  • Singapore PROCESS ENGINEERING SPECIALISTS PTE. LTD. Full time

    About the RolePES International is seeking a skilled Process Equipment Validation Specialist to join our team. As a key member of our team, you will be responsible for ensuring the quality and compliance of our equipment and processes in the Life Sciences industry.Key ResponsibilitiesAssist in qualifying and validating new equipment or replacing existing...


  • Singapore Amaris Consulting Full time

    Job OverviewAmaris Consulting is seeking a highly skilled Certified Pharmaceutical Cleaning Validation Specialist to join our team in Singapore.Estimated Salary:$85,000 - $110,000 per annum, depending on experience.About the RoleWe are looking for a talented individual with experience in cleaning validation within the pharmaceutical or biotech industry. As a...


  • Singapore Micron Full time

    Company OverviewMicron Technology, Inc. is a leading global developer and manufacturer of advanced memory and storage solutions. Our vision is to transform how the world uses information to enrich life for all.About the RoleWe are seeking a highly skilled NAND Product Validation Specialist to join our Non-Volatile Engineering (NVE) Product Engineering...

  • QA Specialist

    2 months ago


    Singapore PHARMAGEND GLOBAL MEDICAL SERVICES PTE. LTD. Full time

    Roles & ResponsibilitiesKEY DUTIES AND RESPONSIBILITES:• Preparation and review of qualification documents e.g., User requirement specification, DQ, IQ, OQ and PQ protocol for equipment, utilities & facility in compliance with the regulatory guidelines.• Execution of qualification and validation activities including process, cleaning, computer system,...


  • Singapore Takeda Full time

    About the Role:The Process Validation Engineer will provide process validation support for Takeda's vaccine manufacturing operations in internal and contract manufacturing locations.ResponsibilitiesDevelop, facilitate, and support process validation strategies and related activities/documentation for drug substance, drug product, and diluent manufacturing...


  • Singapore Thermo Fisher Scientific Full time

    Company Overview: Thermo Fisher Scientific is a leading biotechnology company that enables customers to make the world healthier, cleaner, and safer.Salary: $120,000 - $150,000 per yearJob Description: We are seeking an experienced Senior Molecular Biologist and Validation Specialist to join our team. As a key member of our V&V function, you will play a...

  • Validation Engineer

    2 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...


  • Singapore WANCO MANPOWER PTE LTD Full time

    • Job Summary:The client, a renowned semiconductor company from the USA, is seeking a skilled Validation Engineer to join their team in Singapore. As a leading employer, they offer a supportive and dynamic work environment.• Key Responsibilities:Execute thorough testing of SSDs on test systems, utilizing Protocol Analyzers and oscilloscopes to ensure...