Validation Engineer

ORION PROJECT SERVICES PTE. LTD.; Singapore; On-site; SGD 60,000 - 100,000; Full time

Job summary

Orion Group Life Sciences is recruiting a Validation Engineer for a multinational biopharmaceutical client based in Tuas, Singapore. This is an initial 12-month contract with potential for extension, offering exposure to IQ, OQ, PQ, and cleaning validation within GMP/GAMP frameworks.

You will author validation reports and lead risk assessments, coordinating with QA, Engineering and Manufacturing while maintaining Validation Master Plans and driving continuous improvement.

Qualifications

• 3+ years' validation experience in pharma/biotech manufacturing.
• Degree in Engineering, Life Sciences or related discipline.
• Strong knowledge of GMP and GAMP requirements.
• Experience with equipment qualification, process validation and cleaning validation.
• Strong communication and stakeholder management skills.
• Ability to work effectively within cross-functional teams.

Responsibilities

• Develop and execute validation protocols including IQ, OQ, PQ, process validation and cleaning validation.
• Author validation documentation and final validation reports.
• Lead validation risk assessments and ensure GMP and GAMP compliance.
• Investigate validation-related deviations and support CAPA implementation.
• Coordinate validation activities with cross-functional teams, including Quality Assurance, Engineering and Manufacturing.
• Maintain and update Validation Master Plans.
• Support continuous improvement of validation activities and documentation as required.

Skills

Validation experience

GMP knowledge

Equipment qualification

Process validation

Cleaning validation

Communication skills

Stakeholder management

Cross-functional teamwork

Education

Engineering or Life Sciences degree

Job description

Validation Engineer

Location: Tuas
Contract: Initial 12-month contract with potential to extend
Industry: Biopharmaceutical

Orion Group Life Sciences are currently recruiting a Validation Engineer on behalf of our multinational biopharmaceutical client based in Tuas.

This is an initial 12-month contract with potential to extend.

Key Responsibilities

• Develop and execute validation protocols, including IQ, OQ, PQ, process validation and cleaning validation.
• Author validation documentation and final validation reports.
• Lead validation risk assessments and ensure compliance with GMP and GAMP requirements.
• Investigate validation-related deviations and support CAPA implementation.
• Coordinate validation activities with cross-functional teams, including Quality Assurance, Engineering and Manufacturing.
• Maintain and update Validation Master Plans.
• Support continuous improvement of validation activities and documentation as required.

Requirements

• Degree in Engineering, Life Sciences or a related discipline.
• 3+ years' validation experience within the pharmaceutical or biotechnology manufacturing industry.
• Strong knowledge of GMP and GAMP requirements.
• Experience with equipment qualification, process validation and cleaning validation.
• Strong communication and stakeholder management skills.
• Ability to work effectively within cross-functional teams.