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Validation Engineer (Engineering Specialist)
Our pharmaceutical client based in Carlow have a fantastic opportunity for two Validation Engineers (Engineering Specialist) for candidates interested in a new challenge in a cGMP regulatory environment.
The successful candidate will support multiple validation streams within sterile and GMP-regulated operations.
Sterilisation – Autoclaves, SIP of vessels
Cleaning – Parts Washer and CIP of vessels
Isolator (Filling, Sterility & Material Transfer isolators) – HVAC, VHP, E-Beam and Depyrogenation systems
Controlled Temperature Units (CTU) – Temperature/Humidity Mapping
Filter Validation
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.
Engage cross-functionally with Production, Maintenance and Quality during cycle development and PQ activities.
Lead and support deviation investigations and root cause analysis of system failures or performance issues.
Provide technical input into quality notifications, investigations and regulatory documentation.
Serve as validation representative on cross-functional and global technical projects.
Ensure full compliance with cGMP, global policies and regulatory requirements, including audit readiness and inspection support.
Support continuous improvement through Lean Six Sigma methodologies.
May be required to perform other duties as assigned.
Requirements
Relevant qualification in Pharmaceutical, Biological, Chemical Sciences or Engineering.
Proven experience in GMP manufacturing as an individual contributor within validation.
Knowledge of CTU equipment qualification and of thermal mapping equipment
Thermal mapping skills
Exception / Deviation Management and Change Control.
Proven track 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
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 required
Excellent communication and cross-functional collaboration skills.
Desirable Knowledge and Experience
Equipment Periodic Validation
Equipment Validation Lifecycle
Project Management Skills/Qualification
Filter Validation & Container Closure Validation
Autoclave/SIP Sterilisation Validation
Dry Heat Sterilisation
Isolator Qualification
Vial and Syringe Processing Technologies
Temperature Mapping
Cleaning Validation
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