Senior Process Validator

2 weeks ago

Dublin, Dublin City, Ireland beBeeValidation Full time €65,000 - €84,000
Job Description

The Validation Specialist role is a key position within our organization, responsible for ensuring compliance with current regulations, guidelines, and quality standards.

This individual will work closely with cross-functional teams to deliver process validation, cleaning validation, and continued process verification, contributing to operational excellence and regulatory compliance.

  • 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
  • Generate and maintain GMP-compliant documentation and review manufacturing and regulatory records
  • Promote a strong safety culture and comply with all safety policies
  • Complete all required training and maintain accurate training records

Benefits:

  • A competitive salary and benefits package
  • Opportunities for professional growth and development
  • A collaborative and dynamic work environment
  • A chance to make a meaningful contribution to the success of our organization

Requirements:

  • Primary degree in a scientific discipline
  • Minimum 2 years' experience in a validation role within a regulated environment (relevant equivalent experience considered)
  • Strong technical understanding of manufacturing processes and equipment
  • Knowledge of industry regulations and validation best practices
  • Strong attention to detail and documentation skills
  • Ability to work collaboratively across functions
  • Commitment to safety, quality, and continuous improvement

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