Senior Associate Process Development Engineer

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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.

This role is part of the global Manufacturing, Science and Technology Group (MS&T). The role will provide technical support to the manufacturing areas within Kent Science Park (KSP) and also the wider jazz network (internal and external CMOs) as required.Ensure production processes are robust through trending of data and continued process verification.
Providing input into Process Safety assessments.

Support equipment qualification and process validation activities, including periodic evaluation of systems and processes as part of the validation lifecycle.

Responsible for generation of documentation required for the above activities: protocols, risk assessments, change controls, and reports. Responsible for training out protocols to production as required.

Where a Process is external (at a CMO) provide technical input to ensure that documentation complies with Regulatory dossiers and meets the requirements of the Process Control Strategy (CPPs)

Act as Subject matter expert (SME) for Regulatory, Customer and Internal/ Corporate audits

Support the successful implementation of approved projects and associated business plans within MS&T and production areas. This will be achieved by:-
Acting as “client representative” on key projects and approved business plans

Delivery of all client/group actions in a timely manner to ensure project delivery on time.

Technical input where required ensuring project success.

Build strong cross functional relationships internally and externally.

Required Knowledge, Skills, and Abilities
Experience working in a Pharmaceutical production or development role

Experience at maintaining operational standards to FDA and MHRA regulatory requirements

Excellent computer literacy

Excellent communication skills, including written, presentational and technical writing

Experience in working in cross functional teams (internally and externally). Develops and maintains positive working relationships with others.

Experience in statistics – interpretation and trending of data

Required/Preferred Education and Licenses
A BEng or MEng in chemical/ process engineering would be 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.