Validation Engineer Lead - Cleaning & Process Excellence

amaris act pte. ltd.; Singapore; Presencial; SGD 90.000 - 140.000; Jornada completa

Descripción de la vacante

amaris act pte. ltd. in Singapore is seeking a seasoned Validation Specialist to drive cleaning and process validation activities. You will prepare protocols, execute validation plans, and review results to ensure GMP-compliant documentation.

The role requires collaboration with cross-functional teams, strong analytical skills, and fluent English, with extensive experience in validated systems and change-control processes.

Formación

• 5+ years of validation experience in pharma/biotech, incl. cleaning and process validation.
• Experience preparing, executing, reviewing validation protocols and reports.
• Knowledge of cleaning validation principles, residue limits, sampling, and acceptance criteria.
• Coordinate validation activities and provide cross-functional guidance.

Responsabilidades

• Plan and execute cleaning validation and process validation activities.
• Prepare and review validation protocols, reports, and supporting documentation.
• Define validation approaches, acceptance criteria, and sampling plans in collaboration with technical and quality teams.
• Coordinate validation execution, including sampling, testing, and documentation activities.
• Review and assess validation results against established acceptance criteria.
• Investigate validation deviations and support CAPAs.
• Assess impact of changes on validated processes and procedures.
• Provide technical guidance on validation activities and support issue resolution.
• Ensure validation documentation is complete, accurate, and GMP-compliant.

Conocimientos

Validation experience

Cleaning validation

Process validation

Validation protocols

CAPA & change control

Cross-functional guidance

English fluency

Documentation skills

Analytical skills

Educación

Diploma or Bachelor's degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences, Biotechnology, or related discipline

Descripción del empleo

amaris act pte. ltd. in Singapore is seeking a seasoned Validation Specialist to drive cleaning and process validation activities. You will prepare protocols, execute validation plans, and review results to ensure GMP-compliant documentation.

The role requires collaboration with cross-functional teams, strong analytical skills, and fluent English, with extensive experience in validated systems and change-control processes.