High Salary Senior Validation Expert

1 week ago

Loch Garman, Loch Garman, Ireland beBeeValidation Full time €60,000 - €80,000
Senior Validation Engineer Position

About this role:

We are seeking an experienced and skilled Senior Validation Engineer to join our team. The ideal candidate will have a strong background in validation, quality management, and regulatory compliance.

Responsibilities:

  • Design and execute qualification and validation documentation and cycle development studies.
  • Develop and review change controls.
  • Resolve technical issues during study execution.
  • Engage with production, maintenance, and quality teams during validation activities.
  • Contribute to quality investigations and perform root cause analysis.
  • Support continuous improvement initiatives using Lean Six Sigma methodologies.
  • Represent validation in cross-functional projects and global forums.
  • Ensure compliance with global policies, procedures, regulatory requirements, and cGMP standards.
  • Maintain documentation, participate in audits, and support regulatory submissions.
  • Promote a safe and compliant work culture.
  • Perform other duties as assigned.

Required Skills and Qualifications:

  • Experience in cleaning validation, including CD & PQ of mobile vessels and parts washers, recipe development, verification, and recovery studies.
  • Proven track record in a GMP manufacturing environment.
  • Technical qualifications in pharmaceutical, biological, chemical sciences, or engineering.
  • Experience with deviation management, change control, and leading technical projects.
  • Knowledge of process monitoring systems, automation (DeltaV), and data systems (Pi System) is beneficial.
  • Continuous professional development is desirable.
  • Understanding of regulatory standards (Irish, European, international).
  • Ability to analyze complex data and link findings to equipment performance.
  • Knowledge of equipment and process validation, sterile fill-finish processes, and equipment qualification.
  • Proficiency in Microsoft Office and related applications.
  • Excellent communication and interpersonal skills.

Benefits:

  • Career development opportunities.
  • Training and mentorship programs.
  • A collaborative and supportive work environment.
  • The opportunity to work on challenging projects and contribute to the growth and success of the company.

Additional Requirements:

  • Relevant technical qualification in pharmaceutical, biological, chemical sciences, or engineering.

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