Chief Validation Specialist

2 days ago

Mabalacat, Central Luzon, Philippines beBeeValidation Full time $90,000 - $125,000
Job Overview

This role involves Commissioning, Qualification, and Validation (CQV) Engineering, as well as Computer System Validation (CSV) Engineering. The primary focus is on ensuring that processes, equipment, and computerized systems meet regulatory requirements and industry standards.

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.
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) Engineering and Computer System Validation (CSV) Engineering.
  • Strong technical writing and documentation skills.
  • Strong understanding of regulatory requirements, Data Integrity, and relevant compliance standards.
  • Experience with risk-based validation approaches and methodologies.
  • Excellent analytical and problem-solving skills.
  • Effective communication and interpersonal skills.
Work Environment

Remote work arrangement available, supporting a Monday-to-Friday schedule from 8pm to 5am PH.

Equal Employment Opportunity

The company is committed to equal employment opportunity for all employees, interns, and applicants. This includes prohibiting discrimination based on actual or perceived race, color, religion, sex, national origin, age, disability, genetic information, or any other protected status.

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