Validation Specialist

The role of the Validation Specialist is to implement and execute tasks relating to Process, Facility and Equipment Development at PCI Pharma Services sites. Areas of validation included are: Process Validation (PV), Cleaning Validation (CV), Computer Systems Validation (CSV).

Responsibilities

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. Also to 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.

Requirements

Bachelor’s or associate degree or Diploma / Certificate in Quality / Validation. May substitute experience in lieu of educational requirements.; 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. The successful candidate should display a dynamic and proactive approach to manage problems.; 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.

Nice to have

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