Validation Specialist

• Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department
• Ensuring all validation activities on site relating to Facility, Equipment and Processes meet the expectations of clients but more specifically meet regulatory requirements (HPRA/ FDA)
• Comply with Site Validation Master Plan
• Generate validation protocols for new and existing computer systems, facilities, equipment and processes and review/approve all reports
• Generate and maintain documentation for cleaning validation performed at PCI sites in Ireland
• Execute validation activities, with minimal supervision, in conjunction with Technical, Production and Engineering functions
• Perform sampling in support of validation studies, including AQL, and cleaning validation
• Manage tooling validations and associated documentation
• Ensure the strict implementation of validation procedures plus the timely and accurate completion of all validation documentation
• Support complaint investigations, deviation investigations and change controls as required
• To undertake such tasks and to manage specific or ad hoc projects as and when required to meet business needs and within the scope of the job-holder’s capabilities
• Identify and support opportunities for improving processes and or procedures
• Perform Periodic reviews and revalidations on a scheduled basis
• Work with Validation team to ensure a robust and compliant validation system is in place
• Ensure validation being performed is in line with industry standards and latest regulatory guidelines
• Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company

• Bachelor’s or associate degree or Diploma / Certificate in Quality / Validation
• minimum 2 years’ experience working in Manufacturing or Quality
• Demonstrate interest in Validation
• Capability to follow clear goals, communicate clearly and ensure progress to completion meeting predefined targets
• Ability to manage multiple tasks and set priorities
• Problem Solving and Troubleshooting skills
• Self-motivated with a results driven approach
• Flexibility to work across different shifts on request in line with business needs
• Adaptable and ability to work collaboratively
• Proficient in Microsoft Office products (incl. Excel, PowerPoint, Word, etc.)
• Experience in a GMP or Regulated Environment

Experience in Lean Manufacturing, including experience in Lean tools to develop continuous improvements