Validating Processes Specialist

3 days ago

San Fernando, Central Luzon, Philippines beBeeValidation Full time $90,000 - $120,000
Job Overview

The Validation Engineer role is a remote position focused on ensuring processes, equipment, and computerized systems meet regulatory requirements and industry standards.

Main Responsibilities
  • Develop commissioning, qualification, and validation protocols for equipment, facilities, utilities, and processes.
  • Execute computer system validation activities, including defining user requirements, developing test scripts, and conducting validation testing.
  • Collaborate with cross-functional teams to ensure systems and processes meet quality standards.
  • Perform risk assessments and develop validation plans to mitigate potential risks.
Key Qualifications
  • Bachelor's degree in Engineering or a related technical field.
  • Minimum 3-5 years of validation engineering experience in the pharmaceutical industry.
  • Demonstrated experience in Commissioning, Qualification, Validation (CQV) Engineering and Computer System Validation (CSV) Engineering.
  • Strong technical writing and documentation skills.
  • Knowledge of regulatory requirements, Data Integrity, 21 CFR Part 11 Compliance, GAMP 1-4 or 5.
  • Experience with risk-based validation approaches and methodologies.
  • Excellent analytical and problem-solving skills.
  • Effective communication and interpersonal skills.

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