Validation Engineer - Cleaning and Validation

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.

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