Principal QA Validation Specialist (Fill Finish)

Role Summary

Principal QA Validation Specialist (Fill Finish) responsible for validating and qualifying equipment, systems, and processes in compliance with regulatory standards to support a Fill Finish Facility in Upstate NY.

Responsibilities

• Lead validation efforts for equipment, processes, and systems (including IQ, OQ, PQ).
• Act as a Technical SME in areas including Equipment Qualification, Drug Product Filling Validation, and Automated/Semi-Automated Visual Inspection.
• Validate equipment such as Syringe/Vial Fillers, Inspection Machines, Packaging Machines, and Finished Goods handling systems.
• Present in a ‚Äúpressure test‚Äù scenario the technical area they are SME for.
• Generate, review, and approve master and complete qualification validation protocols, reports, SOPs, and change controls.
• Review, edit and approve deviation notifications, deviation investigations, and corrective actions.
• May supervise, provide direction and assign work to Validations Specialists and/or contingent workers to meet goals and deadlines.
• May present at internal and external (regulatory) audits.

Qualifications

• BS/BA in Engineering, Chemistry, or Life Sciences; years of experience per level: Senior QA Validation Specialist: 5+; Principal QA Validation Specialist: 8+; Staff QA Validation Specialist: 10+.
• May substitute proven experience for education requirement; level determined by qualifications.

Skills

• Expertise in validation processes including automated/semi-automated visual inspection and finished goods handling.
• Strong communication, time management, and problem-solving skills.

Education

• BS/BA in Engineering, Chemistry, or Life Sciences (as noted above).

Additional Requirements

• Gowning and cleanroom environment requirements as specified (e.g., full cleanroom attire).