Sr. Validation Specialist

We are PCI, a global impact company that pioneers and shapes the future of life-changing therapies. The role of the Senior Validation Specialist is to implement and execute tasks relating to operational support for product launches, Process, Facility and Equipment Development at PCI Pharma Services sites.

Requirements

• Support the validation effort for all Strategic Projects on site.
• Ensure all validation activities on site relating to Facility, Equipment and Processes meet the expectations of clients but more specifically meet regulatory requirements (HPRA/FDA).
• Prepare, review and or approval of qualification and/or validation documentation (VMPs, specifications, protocols, reports etc.) in relation to instrument, equipment, facilities (including cold stores), utilities, automated systems, manufacturing processes and cleaning processes including FAT, SAT, IQ, OQ, PQ phases in conjunction with program Quality representation.
• Drive solutions, in conjunction with the appropriate department, to ensure customer related validation problems are communicated and corrective actions are in place and closed in a timely manner.
• Thorough investigation of Quality and Validation issues using Root Cause Analysis methodology and implementation of robust corrective and preventative actions to prevent recurrence.
• Support change controls as required.
• Execute validation activities, with minimal supervision, in conjunction with Technical, Production and Engineering functions.
• Ensure the strict implementation of validation procedures plus the timely and accurate completion of all validation documentation.
• Supports the coordination & scheduling of packaging validation activities in alignment with planning & packaging functions.
• Perform Periodic reviews, revalidations, and continued process verifications on a scheduled basis.
• Support all Regulatory Inspections, Customer visits and Customer audits on validation related queries as required.

Benefits

• Equal Employment Opportunity (EEO) Statement