Validation Engineer II

Overview :

We are seeking an experienced Validation Engineer to independently lead validation activities for equipment, processes, and computerised systems within a pharmaceutical manufacturing environment. The successful candidate will ensure validation compliance with GMP and GAMP requirements while supporting quality, operational excellence, and regulatory readiness.

Location: Tuas, Singapore Duration: 12 Months

Key Responsibilities:

Validation Management

• Develop, execute, and review validation protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Perform process validation, cleaning validation, and computerised system validation activities.
• Author validation reports and ensure accurate documentation of validation outcomes.

Compliance & Risk Assessment

• Lead validation risk assessments and implement appropriate mitigation strategies.
• Ensure all validation activities comply with GMP, GAMP, internal quality standards, and regulatory requirements.
• Maintain validation documentation in an audit-ready state.

Investigation & Continuous Improvement

• Investigate validation-related deviations, non-conformances, and exceptions.
• Support root cause analysis and CAPA implementation.
• Recommend and implement process improvements to enhance validation effectiveness.

Cross-Functional Collaboration

• Coordinate validation activities with Quality Assurance, Engineering, Manufacturing, and other stakeholders.
• Provide validation support during audits, inspections, and regulatory assessments.
• Maintain and update Validation Master Plans (VMP).

Requirements:

• Degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related discipline.
• 4 to 8 years of validation experience within pharmaceutical, biotechnology, or regulated manufacturing environments.
• Hands-on experience with IQ/OQ/PQ, process validation, cleaning validation, and computerised system validation.
• Strong knowledge of GMP, GAMP, validation lifecycle management, and regulatory requirements.
• Experience investigating deviations and supporting CAPA activities.
• Strong analytical, documentation, communication, and stakeholder management skills.

Preferred Skills:

• Experience in sterile, biologics, vaccine, or pharmaceutical manufacturing facilities.
• Knowledge of risk management methodologies and validation software systems.
• Ability to independently manage multiple validation projects and timelines.
• Familiarity with regulatory inspections and audit support activities.

We regret to inform that only shortlisted candidates will be notified.

Job Reference: R25150511 Cammy Li Xin Hui

Allegis Group Singapore Pte Ltd, Company Reg No. 200909448N, EA License No. 10C4544