Senior Validation Specialist

5 hours ago

Cavite City, Calabarzon, Philippines beBeevalidation Full time ₱600,000 - ₱800,000
Job Summary

We are seeking a highly skilled Validation Engineer to join our team. As a Validation Engineer, you will play a crucial role in ensuring that our processes, equipment, and computerized systems meet regulatory requirements and industry standards.

Key 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.
  • Proactively identify opportunities for process improvements in validation activities.
  • Stay abreast of industry trends, regulatory changes, and best practices related to Commissioning, Qualification, Validation (CQV) and Computer System Validation (CSV).
Requirements
  • 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) and Computer System Validation (CSV) Engineering.
  • Strong technical writing and documentation skills.
  • Strong 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.

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

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