Remote Validation Engineer

7 days ago

Dumaguete, Central Visayas, Philippines beBeevalidation Full time ₱6,000,000 - ₱8,000,000
Job Overview

The Validation Specialist role is a remote position that focuses on Commissioning, Qualification, Validation (CQV) Engineering and Computer System Validation (CSV) Engineering.

This job entails developing and executing commissioning, qualification, and validation protocols for equipment, facilities, utilities, and processes. It also involves computer system validation activities such as defining user requirements, developing test scripts, and conducting validation testing.

A successful candidate will collaborate with cross-functional teams to ensure that systems and processes meet regulatory and quality standards. They will perform risk assessments and develop validation plans to mitigate potential risks.

Key responsibilities include generating and maintaining validation documentation, participating in change control processes, investigating deviations related to validation activities, and staying abreast of industry trends and regulatory changes.

Responsibilities:
  • Develop and execute commissioning, qualification, and validation protocols for equipment, facilities, utilities, and processes.
  • Define user requirements, develop test scripts, and conduct validation testing for computer systems.
  • Collaborate with cross-functional teams to ensure compliance with regulatory and quality standards.
  • Perform risk assessments and develop validation plans to mitigate potential risks.
  • Generate and maintain validation documentation.
  • Participate in change control processes to assess the impact of changes on validated systems.
  • Investigate and resolve deviations related to validation activities.
  • Stay abreast of industry trends and regulatory changes.
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, and industry standards.
  • Excellent analytical and problem-solving skills.
  • Effective communication and interpersonal skills.

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