Engineer of Assurance

2 days ago

Mandaue City, Central Visayas, Philippines beBeevalidation Full time ₱4,500,000 - ₱7,500,000
Job Description

The Validation Engineer is a critical role in ensuring the quality and reliability of equipment, processes, and computerized systems. This position involves Commissioning, Qualification, Validation (CQV) Engineering and Computer System Validation (CSV) Engineering to guarantee compliance with regulatory requirements and industry standards.

Key Responsibilities
  • Develop and execute commissioning, qualification, and validation protocols for equipment, facilities, utilities, and processes.
  • Perform risk assessments and develop validation plans to mitigate potential risks.
  • Generate and maintain validation documentation, including protocols, reports, and standard operating procedures (SOPs).
Required Skills and Qualifications
  • Bachelor's degree in Engineering or related technical field.
  • Minimum of 3-5 years of validation engineering experience in the pharmaceutical industry.
  • Demonstrated experience in both Commissioning, Qualification, Validation (CQV) Engineering and Computer System Validation (CSV) Engineering.
  • Strong understanding of regulatory requirements, Data Integrity, 21 CFR Part 11 Compliance, GAMP 1-4 or 5.
Benefits
  • Excellent analytical and problem-solving skills.
  • Effective communication and interpersonal skills.
  • Detail-oriented with strong organizational abilities.

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