Engineering Validation Expert

1 day ago

Las Piñas, National Capital Region, Philippines beBeeValidation Full time ₱1,800,000 - ₱2,700,000
Job Role Summary

The Validation Specialist plays a pivotal role in ensuring the seamless operation of technical systems and processes within a pharmaceutical setting.

Key Responsibilities:
  • Design, execute, and manage commissioning, qualification, and validation protocols for equipment, facilities, utilities, and processes.
  • Conduct comprehensive computer system validation activities, including user requirement definition, test script development, and validation testing.
  • Foster collaboration with cross-functional teams to guarantee that systems and processes adhere to regulatory and quality standards.
  • Analyze potential risks and develop proactive validation plans to mitigate these risks.
  • Maintain accurate and detailed validation documentation, encompassing 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.
  • Continuously identify opportunities for process improvements within validation activities.
Qualification Requirements:
  • Bachelor's degree in Engineering or a related technical field.
  • A minimum of 3-5 years of experience in validation engineering within the pharmaceutical industry.
  • Demonstrated expertise in Commissioning, Qualification, Validation (CQV) Engineering and Computer System Validation (CSV) Engineering.
  • Excellent technical writing and documentation skills.
  • In-depth understanding of regulatory requirements, data integrity, and industry standards.
  • Experience with risk-based validation approaches and methodologies.
  • Strong analytical and problem-solving skills.
  • Effective communication and interpersonal skills.
  • Meticulous attention to detail with strong organizational abilities.

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