Job Title
A Validation Engineer role is currently available on behalf of a leading pharmaceutical company based in Carlow.
This is an initial 11-month contract position.
The key responsibilities of this role include:
* Designing, authoring, reviewing, approving, and executing qualification/validation documentation and cycle development studies in line with the standard approval process.
* Designing, authoring, reviewing, approving, and executing execution/development of change controls.
* Resolving technical issues encountered during study execution.
* Engaging with Production, Maintenance, and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities.
* Providing technical input into quality notifications by authoring/reviewing/approving investigations.
* Performing root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues.
* SUPPORTING continuous improvement through Lean Six Sigma methodologies.
* Serving as a validation representative for cross-functional projects and representing the validation team at global technical forums.
* Driving compliance of Global Policies, Procedures, and Guidelines, regulatory requirements, and executing current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
* Being accountable for compliance via documentation completion, risk assessments, closing out corrective actions, participation in audits and inspections, and proactively highlighting any issues around compliance.
* Supporting regulatory audits and submissions as required.
Required Skills and Qualifications
To be successful in this role, you will need the following skills and qualifications:
* Rlevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification.
* Experience in authoring, reviewing, executing, and approving Isolator Airflow Visualisation/VHP/HVAC Qualification documents.
* Exception/deviation management and change control.
* Demonstratable experience of leading technical related projects.
* Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment.
* Evidence of continuous professional development.
* Knowledge of regulatory/code requirements to Irish, European, and International Codes, Standards, and Practices.
* Ability to analyze and interpret complex data, and link to equipment performance and out of specification findings as appropriate.
* Report, standards, policy writing skills required.
* Equipment and process validation.
* Sterile Fill-Finish processes and equipment.
* Proficiency in Microsoft Office and job-related computer applications.
* Excellent communication, presentation, and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team-oriented manner.
Benefits
We offer:
* A competitive salary.
* An excellent benefits package.
* Opportunities for career growth and development.
* A collaborative and dynamic work environment.
Others
Please note that candidates must have the correct visa to live and work in Ireland.
You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy.
Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert.