Senior Validation Specialist

The ideal candidate will be responsible for supporting cleaning validation, including recovery and cleanability studies. The successful candidate will work in a cGMP regulatory environment and will support qualification/validation documentation and cycle development studies. They will also design and execute equipment and process validation.

Key Responsibilities:

• Design/Author/Review/Approve/Execute qualification/validation documentation and cycle development studies
• 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

Requirements:

• 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

Additional Considerations:

• 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:

• Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification

Job Type: Full-time

Job Function: Quality Assurance