Validation Engineer - Cleaning and Validation at Advanced Manufacturing Tech Solutions in Singapore

Job description

• Location: Singapore, Tuas.
• Industry: Pharmaceutical Manufacturing | Life Sciences

Responsibilities

• Support execution of Cleaning Validation activities for GMP manufacturing equipment and process systems.
• Develop, review, and execute Cleaning Validation protocols and reports.
• Support cleaning validation lifecycle activities in accordance with site procedures and regulatory requirements.
• Define and evaluate cleaning acceptance criteria and residue limits.
• Support product-to-product changeover assessments and cleaning verification strategies.
• Perform and review swab and rinse sampling activities.
• Evaluate cleaning validation data and prepare technical summary reports.
• Participate in risk assessments related to cleaning validation activities.
• Support investigations related to cleaning validation deviations, CAPAs, and change controls.
• Collaborate with Manufacturing, MSAT, Engineering, QA, QC, and Validation teams to ensure successful execution of validation activities.
• Ensure compliance with GMP, Data Integrity, and applicable regulatory guidelines.
• Support inspection readiness and audit activities.

Requirements

• Degree in Engineering, Biotechnology, Pharmaceutical Sciences, Chemistry, Life Sciences, or related discipline.
• Experience in Cleaning Validation within pharmaceutical, biotechnology, or GMP-regulated manufacturing environments.
• Strong understanding of Cleaning Validation lifecycle principles and methodologies.
• Experience developing, executing, and reviewing Cleaning Validation protocols and reports.
• Knowledge of residue limit calculations, acceptance criteria, and risk-based validation approaches.
• Familiarity with swab recovery studies, rinse sampling, and cleaning verification practices.
• Understanding of GMP regulations, Data Integrity requirements, and validation compliance expectations.
• Experience supporting deviation investigations, CAPA implementation, and change control processes.
• Strong technical writing, documentation, and report preparation skills.

Skills

Required

• Cleaning Validation
• GMP regulations
• Data Integrity
• Validation compliance
• Technical writing
• Documentation
• Report preparation