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全职 Validation Engineer - Cleaning and Validation 工作, 薪水, Advanced Manufacturing Tech Solutions 公司招聘中 - Ricebowl

Validation Engineer - Cleaning and Validation

Advanced Manufacturing Tech Solutions

Undisclosed

全职

Singapore

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工作地点

  • Singapore

职位描述

岗位职责

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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