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

Validation Engineer II