Validation Engineer - Cleaning and Validation

Advanced Manufacturing Tech Solutions; Singapore; On-site; SGD 60,000 - 90,000; Full time

Job summary

Advanced Manufacturing Tech Solutions is seeking a Validation Engineer - Cleaning Validation in Singapore. You will support cleaning validation activities for GMP equipment and process systems, and develop validated protocols and reports on site in Tuas.

Apply your expertise in residue limits, acceptance criteria, and risk-based validation. You will collaborate across Manufacturing, MSAT, Engineering, QA, QC, and Validation teams, ensuring data integrity and regulatory compliance throughout the

Qualifications

• Degree in Engineering, Biotechnology, Pharmaceutical Sciences, Chemistry or Life Sciences.
• Experience in Cleaning Validation within GMP-regulated environments.
• Knowledge of residue limits, acceptance criteria and risk-based validation.
• Experience developing and reviewing Cleaning Validation protocols and reports.
• Understanding GMP, Data Integrity and validation compliance expectations.
• Strong technical writing and documentation abilities.

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.

Skills

Cleaning Validation

GMP knowledge

Regulatory compliance

Technical writing

Data Integrity

Validation reports

Documentation

Risk assessment

Education

Engineering/Life Sciences degree

Job description

Validation Engineer - Cleaning Validation

Location: Singapore, Tuas.

Industry: Pharmaceutical Manufacturing | Life Sciences

Key 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.