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
