Manufacturing Process Validator

2 weeks ago

Dublin, Dublin City, Ireland beBeeValidator Full time €60,000 - €85,000
Job Overview

The Validation Specialist plays a critical role in ensuring compliance with current regulations, guidelines, and quality standards. This position works closely with cross-functional teams to deliver process validation, cleaning validation, and continued process verification, contributing to operational excellence and regulatory compliance.

Key Responsibilities:
  • Support small molecule validation activities in compliance with regulations, guidelines, and quality standards.
  • Execute process validation, cleaning validation, and continued process verification.
  • Prepare, review, and execute validation documentation, plans, protocols, reports, and deviations.
  • Maintain policies, SOPs, and related documentation for manufacturing process and cleaning validation.
  • Act as validation representative in cross-functional project teams.
  • Support ongoing process control through data review, report generation, and implementation of control limits.
  • Review process-related change controls for validation impact.
  • Contribute to continuous improvement initiatives.
  • Support training of validation personnel and maintain SOPs, forms, and training materials.
  • Promote a strong safety culture and comply with all safety policies.
  • Complete all required training and maintain accurate training records.
Requirements and Qualifications:
  • A strong technical understanding of manufacturing processes and equipment is essential.
  • Knowledge of industry regulations and validation best practices is necessary.
  • Excellent documentation skills are required.

The ideal candidate will possess the skills and qualifications mentioned above.

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