Engineering Validation Specialist

1 week ago

Bacoor, Calabarzon, Philippines beBeeValidation Full time ₱1,000,000 - ₱1,500,000
Job Role

We are seeking a Validation Engineer to support the commissioning, qualification and validation of equipment, facilities, utilities and processes. This role is focused on ensuring that systems and processes meet regulatory requirements and industry standards.

Main Responsibilities
  • Develop and execute 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 that systems and processes meet regulatory and quality 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 regulatory requirements.
Required Skills and 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.
  • Strong understanding of regulatory requirements, Data Integrity, 21 CFR Part 11 Compliance, GAMP 1-4 or 5.
  • Experience with risk-based validation approaches and methodologies.
Benefits
  • A competitive salary and benefits package.
  • The opportunity to work with a dynamic team.
  • Professional development and growth opportunities.
Equal Opportunity Employment

We are an equal opportunities employer and welcome applications from all qualified candidates. We are committed to creating a diverse and inclusive workplace culture.

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