Validation Engineer (Engineering Specialist)

Ref.

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