Validation Engineer II

Overview:

We are currently on the lookout for a skilled Validation Engineer to take the lead on validation initiatives for equipment, processes, and computerized systems in a pharmaceutical manufacturing setting. The ideal candidate will ensure that validation practices adhere to GMP and GAMP standards while fostering quality, operational excellence, and preparedness for regulatory compliance.

Location: Tuas, Singapore

Duration: 12 Months

Key Responsibilities:

Validation Management

• Design, implement, and assess validation protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Conduct activities related to process validation, cleaning validation, and computerized system validation.
• Create validation reports and ensure comprehensive documentation of validation results.

Compliance & Risk Assessment

• Oversee validation risk assessments and execute suitable mitigation strategies.
• Guarantee that all validation tasks meet GMP, GAMP, internal quality standards, and regulatory guidelines.
• Keep validation documentation in a state ready for audits.

Investigation & Continuous Improvement

• Examine validation-related deviations, non-conformities, and exceptions.
• Assist in root cause analysis and the implementation of CAPA.
• Propose and apply process enhancements to improve validation efficiency.

Cross-Functional Collaboration

• Collaborate on validation activities with Quality Assurance, Engineering, Manufacturing, and other relevant parties.
• Provide validation assistance during audits, inspections, and regulatory evaluations.
• Update and maintain Validation Master Plans (VMP).

Requirements:

• Degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related field.
• 4 to 8 years of validation experience in pharmaceutical, biotechnology, or regulated manufacturing settings.
• Practical experience with IQ/OQ/PQ, process validation, cleaning validation, and computerized system validation.
• In-depth knowledge of GMP, GAMP, validation lifecycle management, and regulatory requirements.
• Experience in investigating deviations and assisting with CAPA activities.
• Excellent analytical, documentation, communication, and stakeholder management skills.

Preferred Skills:

• Background in sterile, biologics, vaccine, or pharmaceutical manufacturing environments.
• Familiarity with risk management methodologies and validation software platforms.
• Capability to independently oversee multiple validation projects and deadlines.
• Awareness of regulatory inspections and audit support activities.

We regret to inform you that only candidates selected for an interview will be contacted.

Job Reference: R25150511 Cammy Li Xin Hui

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