Senior Validation Specialist
Job Details
- Req ID:
- R010526
- Location:
- Sittingbourne, UK
- Category:
- Technical Operations
If you are a current Jazz employee please apply via the Internal Career site.
Jazz Pharmaceuticals is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases — often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information.
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)
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.
The successful candidate will also be eligible to participate in various benefits offerings, including, but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation. For more information on our Benefits offerings please click here: https://careers.jazzpharma.com/benefits.html.