This role sits with a global organisation with operations in North Dublin. This is an innovative, patient centric organisation with sites across the US & Europe. The business unit here in Ireland is heavily resourced and has expanded over the last three years as the Global R&D Hub boasting state of the art labs & high spec test suites with top class equipment. In existence over 150 years this company has grown through a blend of innovative product development key product acquisitions.
The QA Validation Engineer is responsible for supporting operation of the validation process, providing validation support to manufacturing, cleaning, utilities and laboratory operations. The role reports to the QA Lead.
- Provide leadership and SME knowledge in the area of validation (process, cleaning and Utilities) and across all levels at the site, ensuring compliance with current industry regulations, guidelines and trends.
- Pre and post approval of qualification and validation protocols, SRs and associated data for conformance to associated regulations and acceptance criteria. Also ensuring the effectiveness of such documents in achieving site compliance in a focused and concise manner.
- Ensure alignment and compliance of Manufacturing Validation processes and procedures with Policies and Corporate SOP's in this area
- Partner with the Global Quality Compliance / CSV team on all compliance and improvement initiatives applicable to own work
- Prepare and maintain procedures, reports and plans associated with validation. This includes the site validation master plans.
- Contribute to and approve where required all QMS related documents (including change controls and deviations) as validation SME. Provide leadership as required to major/critical events as validation SME.
- Serving as a key member to present and support validation processes and programs at internal and external (including health authority) inspections.
- Participate in and lead as required cross-functional project teams as the validation representative/lead.
- Identify and lead continuous improvement (CI) and innovation programs within the validation process across the site. Participate in CI programs to implement improvements in manufacturing, engineering and quality functions as required
- Minimum of Level 8 in scientific/engineering discipline preferred plus 5+ years' experience working as a Validation Specialist or Quality Engineer in a Pharmaceutical or Biopharmaceutical manufacturing
- Some exceptions made for those candidates demonstrating equivalent knowledge and having substantial relevant experience.
- Must have prior experience in DS/DP, process performance qualification and validation and site inspection readiness.
- Ideally would have previous experience within a startup facility.
To learn more about this role please contact Emma Mullen on +353 87 636 9263.