This is an exciting opportunity for a fantastic Senior Engineering Specialist for candidates interested in a new challenge in a cGMP regulatory environment. The successful candidate will support Cleaning Validation including Recovery/Cleanability studies.
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 Carlow.
* May be required to perform other duties as assigned.
Skills
* Experience in cleaning validation including but not limited to CD & PQ of mobile vessels (CIP) and parts washers (COP) including recipe development & optimisation, cleaning verification, cleanability and recovery studies using TOC, ICP & swab methods, acceptable residual limit determination, worst case soil matrices & strategy development.
* 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.
* 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.
Experience
* Filter Validation
* CCI qualification
* Shipping Qualification
* Equipment Periodic Validation
* Equipment Validation Lifecycle
* Project Management Skills/Qualification
* Autoclave/SIP Sterilisation Validation
* Dry Heat Sterilisation
* Isolator VHP/HVAC Qualification
* Controlled Temperature Units/Equipment Qualification
* Vial and Syringe Processing Technologies
Qualifications & Education
* Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification
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