Validation Specialist

ONE STOP ENGINEERING PTE. LTD.; Singapore; On-site; SGD 70,000 - 120,000; Full time

Job summary

ONE STOP ENGINEERING PTE. LTD. is seeking a validation professional in Singapore to develop and execute validation protocols (IQ/OQ/PQ, process and cleaning validation) and to author final validation reports.

The role involves leading risk assessments and ensuring GMP/GAMP compliance, investigating deviations, and coordinating with QA, Engineering, and Manufacturing. The candidate will maintain the Validation Master Plan and support CAPA implementation, with a strong focus on documentation

Qualifications

• Proficiency in documenting validation activities, SOPs, and reports.
• Strong communication skills for cross-functional collaboration.
• Analytical mindset with systematic approach to investigations.

Responsibilities

• Develop and execute validation protocols (IQ/OQ/PQ, process validation, cleaning validation).
• Author validation final reports and ensure timely completion.
• Lead validation risk assessments and ensure compliance with GMP/GAMP requirements.
• Investigate deviations and support CAPA implementation.
• Coordinate with cross‑functional teams (QA, Engineering, Manufacturing).
• Maintain and update Validation Master Plans (VMP).

Skills

Documentation

Communication

Problem-solving

Education

Degree in Engineering, Life Sciences, Biotechnology, or related field

Job description

Key Responsibilities

• Develop and execute validation protocols (IQ/OQ/PQ, process validation, cleaning validation)

• Author validation final reports and ensure timely completion

• Lead validation risk assessments and ensure compliance with GMP/GAMP requirements

• Investigate deviations and support CAPA implementation

• Coordinate with cross‑functional teams (QA, Engineering, Manufacturing)

• Maintain and update Validation Master Plans (VMP)

Qualifications & Experience

• Degree in Engineering, Life Sciences, Biotechnology, or related field

• 4 – 8 years of validation experience in pharmaceutical or biotech manufacturing

• Strong knowledge of GMP, GAMP, and ICH guidelines

• Excellent documentation, communication, and problem-solving skills