Validation Engineer

5 days ago

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

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.
Tell employers what skills you have
Airflow
Technical Writing
Ability To Work Independently
Biosafety
GMP
Protocol
Biotechnology
Equipment Qualification
Visualization
Instrumentation
Life Sciences
Manufacturing
Commissioning
Autoclave
Calibration
Mapping

  • Validation Engineer

    1 week ago

    Singapore ASIA GMP PTE. LTD. Full time

    Prepare the IQ, OQ, PQ, Report, and all associated Validation documents, review with the clients, and route for approval. - Supports Validation activities related to the validation of facility, and equipment. - Collaborate with other Engineering functions, End-User, and Quality teams to ensure the Validation activities are completed as planned. - Review...

  • Validation Engineer

    5 days ago

    Singapore ANTER CONSULTING PTE. LTD. Full time

    We're currently on the lookout for Validation Engineers for the Pharmaceutical Industry. - Developing and executing validation protocols for new processes, equipment, and systems, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). - Reviewing and approving validation documentation, including...

  • Validation Engineer

    1 week ago

    Singapore PROCESS ENGINEERING SPECIALISTS PTE. LTD. Full time

    Process Engineering Specialists is a multi-discipline consultancy providing specialist project management, validation and automation services to our clients throughout Asia’s pharmaceutical and medical device sector. We are currently recruiting for the following Singapore based roles: **Validation Engineers We are hiring Validation engineers with 5 - 10...

  • Validation Engineer

    1 week ago

    Singapore No deviation Full time

    Join to apply for the Validation Engineer role at No deviation 1 day ago Be among the first 25 applicants Join to apply for the Validation Engineer role at No deviation Get AI-powered advice on this job and more exclusive features. About No Deviation At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the...

  • Validation Engineer

    2 weeks ago

    Singapore ONE STOP ENGINEERING PTE. LTD. Full time

    Validation 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, including aerospace,...

  • Validation Engineer

    2 weeks ago

    Singapore Coalesce Management Consulting Full time

    Get AI-powered advice on this job and more exclusive features. At 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. Position: Validation Engineer Job Description: We...

  • Validation Engineer

    5 days ago

    Singapore Rapsodo Full time

    Rapsodo is a Sports Technology company with offices in the USA, Singapore, Turkey & Japan. We develop sports analytics products that are data-driven, portable and easy-to-use to empower athletes at all skill levels to analyse and improve their performance. From Major League Baseball star pitchers to Golf tour players, athletes use Rapsodo technology to up...

  • Validation Engineer

    2 days ago

    Singapore Peoplebank Full time

    This Role: Validation Engineer Job Description & Requirements: **Laboratory validation** As a Functional Validation Engineer, you will be involved in validating all the division's products. This activity will aim to ensure the adequacy of the functionalities and performances of the product with the specifications by relying on FPGA prototyping first, and on...

  • Validation Engineer

    1 week ago

    Singapore NO DEVIATION PTE. LTD. Full time $80,000 - $120,000 per year

    About No deviationAt No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful...

  • Validation Engineer

    5 days ago

    Singapore PSC BIOTECH PTE. LTD. Full time

    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 biotech/pharmaceutical environment as a...