Validation Engineer

3 days ago


Singapore AMARIS CONSULTING PTE. LTD. Full time
Roles & Responsibilities

Job Description

  • Validation Protocols: Develop, execute, and document validation protocols for equipment, processes, and systems in compliance with GMP regulations and industry standards.
  • Documentation: Prepare and review validation documentation, including protocols, reports, and standard operating procedures (SOPs), ensuring accuracy and completeness.
  • Compliance: Ensure that all validation activities adhere to GMP guidelines, regulatory requirements, and internal quality standards.
  • Risk Management: Identify and assess potential risks in validation processes, and implement strategies to mitigate those risks.
  • Continuous Improvement: Collaborate with cross-functional teams to optimize validation processes and procedures, contributing to continuous improvement initiatives.
  • Training and Support: Provide training and support to facility staff on validation procedures and compliance requirements.
  • Troubleshooting: Investigate and resolve validation-related issues and deviations, providing technical expertise and guidance as needed.

Requirements

  • Bachelor’s degree in Engineering, Life Sciences, or a related field.
  • Validation engineering within a GMP environment, with a strong understanding of validation principles and regulatory requirements.
  • Proficiency in validation methodologies, risk management, and quality systems. Familiarity with FDA regulations, EU guidelines, and other relevant standards.
  • Excellent analytical, problem-solving, and organizational skills. Strong attention to detail and the ability to work independently and as part of a team.
  • Effective written and verbal communication skills, with the ability to present complex information clearly to diverse audiences.

Tell employers what skills you have

Troubleshooting
FDA
Risk Assessment
Strong Attention To Detail
Ability To Work Independently
GMP
Risk Management
Adaptability
Compliance
Regulatory Requirements
Life Sciences
Manufacturing
Commissioning
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