Validation Engineer II

ALLEGIS GROUP SINGAPORE PRIVATE LIMITED; Singapore; On-site; SGD 70,000 - 110,000; Full time

Job summary

Allegis Group Singapore Pte Ltd in Tuas, Singapore is seeking an experienced Validation Engineer to independently lead validation activities for equipment, processes, and computerised systems within a pharmaceutical manufacturing environment.

The role requires hands-on IQ/OQ/PQ, process and cleaning validation, and strong GMP/GAMP knowledge, with a focus on audit readiness, risk assessments, CAPA, and cross-functional collaboration.

Qualifications

• Degree in Engineering, Life Sciences, Pharmaceutical Sciences, or related discipline.
• 4–8 years of validation experience in pharma/regulated manufacturing.
• Hands-on 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 and stakeholder management skills.

Responsibilities

• Develop, execute, and review validation protocols including IQ, OQ, and PQ.
• Perform process validation, cleaning validation, and computerized system validation activities.
• Author validation reports and ensure accurate documentation of validation outcomes.
• Lead validation risk assessments and implement mitigation strategies.
• Coordinate validation activities with QA, Engineering, Manufacturing, and other stakeholders.
• Maintain and update Validation Master Plans (VMP) and provide audit support.

Skills

IQ/OQ/PQ experience

Process validation

GMP knowledge

GAMP knowledge

Documentation

Stakeholder management

Education

Bachelor's degree in Engineering/Life Sciences/Pharmaceutical Sciences

Tools

Validation software systems

Job description

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