Pharmaceutical & Biotechnology

Validation Engineer

Posted 5 days ago
Contract
Carlow, County Carlow, Ireland
42067903

Desired Skills: validation,isolators,HVAC,VHP

The role:

PE Global is currently recruiting for a Validation Engineer on behalf of a leading pharmaceutical company based in Carlow. This is an initial 11-month contract role.

Responsibilities:

Design/Author/Review/Approve/Execute qualification/validation documentation and cycle development studies in line with the standard approval process.
Design/Author/Review/Approve/Execute Execution/development of change controls.
Resolving technical issues encountered during study execution.
Engagement with Production, Maintenance and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities.
Technical input into quality notification by authoring/reviewing/approving investigations.
Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues.
Support continuous improvement through Lean Six Sigma methodologies.
Serve as validation representative for cross functional projects and represent the validation team at global technical forums
Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute 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.
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.
Work collaboratively to drive a safe and compliant culture in Carlow.
May be required to perform other duties as assigned.

Education and Experience:

Relevant 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 would be beneficial and desirable
Evidence of continuous professional development is desirable.
Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
Ability to analyse 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 orientated manner.