Senior Validation Specialist

Overview

Reporting to the Engineering department, this role will support delivery of the Site Validation Master Plan (SVMP) Schedule, overseeing validation/ qualification activities across the Jazz KSP site including manufacturing plant equipment, laboratory analytical equipment and utility/ facility qualification, ensuring compliance with Jazz procedures, Regulatory requirements and GMP (Good Manufacturing Practice).

Essential Functions/Responsibilities

• To generate validation/ qualification documentation (following Jazz templates/ procedures) associated with manufacturing plant equipment, laboratory analytical equipment and utilities/ facilities across commercial and development space. This will include routine requalification works (as per periodic evaluation of systems) as well as introduction of new equipment (supporting Capital Project team).
• If a vendor is authoring validation documentation (e.g. FAT, SAT, IQ etc), to review / approve documentation.
• To lead/ support execution of validation/ qualification activities in collaboration with system owning department.
• Visit equipment vendor facilities to execute FAT (Factory Acceptance Test) as required.
• Manage activities as per the SVMP and report progress via the SVMP.
• Manage third party suppliers with respect to qualification and validation activities (where required).
• Provide SME impact assessments for change controls involving validation/ qualification activities.
• Own and deliver Change Actions and CAPAs within eQMS for validation/ qualification activities.
• Lead deviations related to qualification incidents.
• Support equipment decommissioning activities as required.
• Matrix manage teams as required to deliver a validation project.

Required Knowledge, Skills, and Abilities

• 5+ years relevant work experience in the pharmaceutical, biotechnology or related industry where principles of GMP apply
• An appreciation of validation principles
• Experience in technical writing, and good knowledge of Microsoft Office IT packages (Word, Excel, Powerpoint).
• Ability to collaborate across cross functional teams, and matrix manage teams for delivery of a validation project.
• Excellent communication skills

Required/Preferred Education and Licenses

• A bachelor's degree in science, engineering or related discipline (preferred)