Remote Validation Engineer

6 days ago

Manila, National Capital Region, Philippines beBeeValidationEngineer Full time ₱900,000 - ₱1,200,000
Job Overview

This role is a remote position that supports a M-F 8pm - 5am PH schedule. It focuses on ensuring processes, equipment and computer systems meet regulatory requirements and industry standards.

Key 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 and regulatory standards.
  • Perform risk assessments and develop validation plans to mitigate potential risks.
  • Generate and maintain validation documentation including protocols, reports, and standard operating procedures (SOPs).
  • Participate in change control processes to assess the impact of changes on validated systems.
  • Investigate and resolve deviations related to validation activities, ensuring compliance with regulations.
Required Qualifications
  • Bachelor's degree in Engineering or a 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 technical writing and documentation skills.
  • Understanding of regulatory requirements, data integrity, and 21 CFR Part 11 Compliance.
  • Experience with risk-based validation approaches and methodologies.
  • Excellent analytical and problem-solving skills.
  • Effective communication and interpersonal skills.
  • Detail-oriented with strong organizational abilities.
About Us

We are committed to a policy of equal employment opportunity. We prohibit discrimination against qualified employees and applicants in all aspects of employment.

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