VALIDATION SPECIALIST...

Role Description :

Our site are excited to offer a fantastic Engineering Specialist (Validation) opportunity for candidates interested in a new challenge in a cGMP regulatory environment. The successful candidates will support several aspects of Validation. The roles available that will require experienced, energetic and committed engineers are in the following areas :

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

Requirements

Role Functions :

Bring energy, knowledge, innovation to carry out the following :

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 site.

May be required to perform other duties as assigned.

Experience,Knowledge & Skills :

In order to excel in this role, you will more than likely have considerable experience in a comparable role, with experience operating as individual contributor adding value to the business in a GMP manufacturing setting, as well as the following qualifications / skills :

Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence.

Knowledge of CTU equipment qualification

Knowledge of thermal mapping equipment

Thermal mapping skills

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 required

Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.

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

The successful candidate will be required to work both independently and in a cross-functional team to accomplish validation project objectives. Works with moderate work direction and is skilled and knowledgeable to the position.

Qualifications & Education :

Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence.