Validation Engineer

4 days ago

Singapore NO DEVIATION PTE. LTD. Full time

About No deviation

At 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 projects and drive innovation.

We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.

Position Overview

We are seeking a skilled Validation Engineer with 3 to 5 years of hands-on experience in aseptic operations and fill–finish environments. The ideal candidate will have proven expertise in Aseptic Process Simulation (APS/media fill), filling lines, isolators, and thermal mapping & autoclave qualification. You will play a key role in supporting qualification, validation, and manufacturing readiness activities for sterile manufacturing operations.

Key Responsibilities

  • Plan, execute, and document Aseptic Process Simulations (APS/media fills) in compliance with regulatory requirements.
  • Lead or support qualification of filling lines, isolators, RABS, and associated aseptic equipment.
  • Perform equipment qualification (IQ/OQ/PQ) for sterile manufacturing systems.
  • Conduct thermal mapping studies for cold rooms, incubators, freezers, autoclaves, and other controlled environments.
  • Execute autoclave validation including cycle development, load pattern qualification, BI/CI studies, and documentation review.
  • Support validation activities for sterile utilities (e.g., clean steam, WFI, compressed gases).
  • Draft and execute validation protocols and reports in accordance with GMP and internal procedures.
  • Collaborate closely with Manufacturing, QA, Engineering, MSAT, and other cross-functional teams.
  • Review URS, risk assessments, and change controls related to sterile manufacturing equipment.
  • Investigate validation-related deviations and propose corrective/preventive actions.

Required Qualifications

  • Degree in Engineering, Life Sciences, Pharmaceutical Sciences or related field.
  • 3 to 5 years of experience in pharmaceutical aseptic operations or validation.
  • Practical experience in:

    Aseptic Process Simulation (APS/media fills)

    Filling line and isolator/RABS qualification

    Equipment thermal mapping (Kaye Validator or similar)

    Autoclave/SIP validation

    Strong understanding of GMP, Annex 1, PDA TR22/TR44/TR60, and validation lifecycle principles.
  • Good documentation and technical writing skills (protocols, reports, investigations).
  • Strong problem-solving skills and ability to work hands-on on the shopfloor.
  • Excellent communication and teamwork abilities

Why join us?

  • Generous Leave Policy.
  • Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
  • Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
  • Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
  • Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.

How to apply

Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team

Please submit your resume, outlining your qualifications and experience relevant to the role, here.

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