Senior Validation Engineer

ref. 01272

Senior Validation Engineer

Asset Recruitment is recruiting a Senior Validation Engineer for a contract role, on behalf of our client, a growing pharmaceutical manufacturer in Carlow. The successful candidate will join the Process Engineering Group on site and report to the Technical Engineering Manager.

Primary responsibilities for this role include Project validation support for equipment performance qualifications (specifically cleaning and sterilization validation); Authoring project validation master plans; SOP and documentation updates; Resolving technical issues encountered during study execution
and authoring validation protocols and final reports, executing validation studies, analysis of validation data.

Responsibilities

• Design/Author/Review/Approve/Execute development of change controls and qualification /validation of documentation and cycle development studies in line with the standard approval process.
• Serve as validation representative for cross functional projects and represent the validation team at global technical forums
• 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.
• Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute cGMP practices in the performance of day-to-day activities and all applicable functions.
• Accountable for compliance via documentation completion, risk assessments, closing out corrective actions, participation in audits and inspections.
• Proactively highlight any issues around compliance.
• Supporting regulatory audits and submissions as required.
• Support continuous improvement through Lean Six Sigma methodologies.
• May be required to perform other duties as assigned.

In order to excel in this role, you will more than likely have:

• Engineering or scientific background. Equipment Validation and Sterilization Validation. Strong technical writing and oral communication skills.
• Minimal work direction needed, highly skilled and knowledgeable to the position.
• 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.
• Demonstratable experience of leading technical related projects.
• 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.
• 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.
• Sterile Fill-Finish processes and equipment.
• Excellent communication, presentation, and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.
• Proficiency in Microsoft Office and job-related computer applications

Desirable

• CCI qualification
• Filter Validation
• Shipping Qualification
• Equipment Periodic Validation
• Equipment Validation Lifecycle
• Dry Heat Sterilisation
• Isolator VHP/HVAC Qualification
• Project Management Skills/Qualification
• Autoclave/SIP Sterilisation Validation
• Vial and Syringe Processing Technologies
• Controlled Temperature Units/Equipment Qualification