Validation Engineer

6 days ago


Singapore PHARMENG TECHNOLOGY PTE. LTD. Full time

We are looking for a Validation Engineer to support a range of qualification and validation activities across critical equipment and controlled environments. This role involves the execution of temperature mapping, equipment validation, protocol development, and performance verification to ensure compliance with regulatory standards and internal quality systems.

Key Responsibilities:

- Temperature Mapping & Environmental Qualification:

- Conduct thermal mapping studies for Cold Rooms (2°C to 8°C), Freezers, and Incubators using Kaye AVS (Advanced Validation System).
- Prepare and execute IOPQ protocols, perform data analysis, and compile comprehensive validation summary reports.

Autoclave Validation:

- Manage requalification of site autoclaves and qualification of new units, ensuring alignment with cGMP standards.
- Support introduction of new loads such as towel packs and perform specialized tests like the Air Detector Test.
- Develop and execute SOPs, OPQ protocols, and performance verification plans for all validated loads.

Equipment Validation:

- Validate and qualify Kaye Validator AVS systems through IOQ protocol development, execution, and reporting.
- Support calibration and maintenance of validation instrumentation and document performance accordingly.

Airflow Visualization Studies:

- Perform smoke studies (air visualization) for biosafety cabinets (BSCs), cleanroom zones, and equipment doors in compliance with cleanroom standards.
- Execute protocols and prepare clear and accurate documentation including study reports.

Documentation & Compliance:

- Draft validation documentation including protocols, deviation reports, and final summary reports.
- Identify and resolve discrepancies in validation findings, escalating issues as needed.
- Prepare and maintain validation maintenance reports for facility and equipment (F&E).

**Requirements**:

- Bachelor’s Degree or Diploma in Engineering, Life Sciences, or a related technical discipline.
- Solid experience in equipment qualification, environmental validation, and temperature mapping using Kaye AVS.
- Knowledge of regulatory standards including cGMP, GDP, and GxP.
- Strong understanding of validation lifecycle: IQ, OQ, PQ, and requalification.
- Excellent technical writing, data analysis, and problem-solving skills.Ability to work independently and collaboratively across functional teams.

Preferred Qualifications:

- Previous experience in pharmaceutical, biotechnology, or regulated manufacturing environments.
- Familiarity with cleanroom validation and environmental monitoring standards.


  • Validation Engineer

    2 weeks ago


    Singapore GDMC Full time

    **Validation Engineer / Validation Manager**: At Genetic Design and Magic Corporation (GDMC), our mission is to exponentially increase the availability of genetic medicines and change millions of patients' lives. We achieve this by partnering and supporting early-stage companies and investigators with innovative therapeutic modalities such as gene therapies...

  • Engineer Validation

    4 days ago


    Singapore Manufacturing & Operations Full time

    Job Description The Validation Engineer is responsible for ensuring that medical devices and manufacturing processes meet required quality standards and regulatory requirements. It includes leading and/or executing validation activities, including equipment, process, test method, and software validation, to ensure that products are manufactured consistently...

  • Validation Engineer

    4 days ago


    Singapore COALESCE MANAGEMENT CONSULTING PTE. LIMITED Full time

    **Position: Validation Engineer** We are Coalesce Management Consulting - 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 and are looking for a Validation Engineer to...

  • Validation Engineer

    2 weeks ago


    Singapore ANTER CONSULTING PTE. LTD. Full time $90,000 - $120,000 per year

    About the RoleWe are looking for an experienced Validation Engineer to support the Commissioning, Qualification, and Validation (CQV) activities for an ongoing fill-finish expansion project. This mid-level role will involve executing qualification protocols, supporting commissioning activities, and ensuring all systems (utility and process equipment) meet...


  • Singapore NOVEXX PTE. LTD. Full time

    Contributes to validation planning and assists with carrying out medium- to large-scale projects that require customized, risk-based execution strategies, problem investigations, and troubleshooting while meeting project timelines. Utilizes expertise and input from Subject Matter Experts to perform effective risk assessments and develop experimental designs...

  • Engineer (Validation)

    2 weeks ago


    Singapore Lonza Full time $80,000 - $120,000 per year

    Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small,...

  • Validation Engineer

    4 days ago


    Singapore PSC BIOTECH PTE. LTD. Full time

    **Job Description & Requirements**: - Completing work assignments as specified by the Validation Project Manager - Providing timely updates to the Validation Project Manager - Adhering to the proper site safety practices; wearing adequate safety equipment when required - Completing timesheets and expense reports in a timely manner - Working in a...

  • Validation Engineer

    3 days ago


    Singapore ANTER CONSULTING PTE. LTD. Full time

    **Key responsibilities**: - Perform Process Validation activities. Schedule own tasks to be performed as well as tasks for other Specialists as determined by the Validation Manager - Perform change control assessments for GMP equipment and associated validation activities to ensure compliance with regulatory requirements - Program, organize, and maintain...

  • Validation Engineer

    1 week ago


    Singapore J P INFOTEC PTE. LTD. Full time

    Si Validation Engineer : Programming language – C & Python Good Understanding of SOC architectures and validation of Integrated IP's Test plan development and test content writing based on design specifications, architecture document & end use case scenarios for SOC's Silicon bring up, initial power-on, bootup & functional testing Preferred Memory & PCIE...

  • Validation Engineer

    1 week ago


    Singapore ESCO ASTER PTE. LTD. Full time

    The Opportunity Esco Lifesciences Group is Singapore's most globalized life sciences company, with annual revenues close to SGD 200M and global operations in over 42 locations and 26 direct countries across North America, Europe, Asia, Oceania. Esco Aster Pte Ltd is an affiliate of Esco Lifesciences Group and was first incorporated in 2017. Esco Aster is a...