QA Validation Engineer
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| Job Type | Permanent |
| Area | Dublin |
| Sector | EngineeringQualityOperations & Manufacturing |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #2080 |
| Job Views | 302 |
- Description
- We have a permanent opening available for a QA Validation Engineer at our Clients drug substance manufacturing facility in Dublin. In this role you will be responsible for supporting operation of the validation process, providing validation support to manufacturing, cleaning, utilities and laboratory operations.
Why you should apply:
The company is dedicated to diversity and inclusion and diversity, a culture empowering all people.
A global focus, ensuring continuous investment in people and portfolio.
They are an industry leader with a start-up mentality, but long history spanning more than 150 years.
What you will be doing:
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. Documents including but not limited to:
Qualification of premises, equipment and utilities.
Computer system qualification.
Laboratory equipment validation.
Process validation.
Cleaning validation.
Site validation plans.
Annual Reports.
Ensure alignment and compliance of site Manufacturing Validation processes and procedures with company 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.
Accountable for completing activities within required timelines.
Proactively highlight and resolve any issues around compliance.
Willingly accepts challenging assignments.
What you need to apply:
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 facility.
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.
Previous experience within a start-up facility an advantage
