Process Technician Senior Coordinator

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  for more information. Brief

Description:

The Process Technician Senior Coordinator is required to assist in development and manufacture of research pharmaceutical formulations for use in clinical trials, as well as assisting in all commercial manufacturing and packaging processes within Botanical Drug Product (BDP), including Clinical Trial packing using a series of well-defined and documented manufacturing procedures whilst being in compliance with Health and Safety (H&S) and current Good Manufacturing Practices (cGMP) requirements.

Essential Functions/Responsibilities Quality is a primary focus to ensure all aspects of cGMP are met and product quality is not compromised. The workload is varied with the core areas of responsibility listed below:
The job holder is responsible for maintaining cGxP and EH&S knowledge applicable to the job. Execute manufacture of clinical formulations. Maintenance of the manufacturing facility, including cleaning and 6S. Ensure delivery against schedule, for all production activities. Assist in the departmental controlled drug reconciliation. Ensure all Production batch documentation has been processed in accordance with cGMP and current procedures. To perform a leading and proactive role within the production areas to ensure procedures are followed correctly and tasks completed in a timely manner.

Perform routine micro testing in the GMP facilities Liaising with other departments regarding production scheduling, including supply chain, warehouse, engineering, Pharm Dev, QC and QA. Training of other technicians on new processes/changes to manufacturing techniques. Identifying areas for improvement and implementing these improvements where applicable across all Production processes/working practices. Completing additional tasks assigned by production management that are outside the core duties described above.

Required Knowledge, Skills, and Abilities Carries out their work in a way that will not adversely affect their own, or others, health, safety and security or the environment and reports any shortcomings in company arrangements. Responsible all aspects of the manufacturing processes to ensure all product are made accordance with cGMP standards, both as an initiator and checker. Recording of manufacturing/process conditions in batch documentation and equipment/area logbooks.

Complete area/equipment cleaning procedures to high standards as illustrated in cGMP practices. The job holder may be called upon to provide cover for other internal departments, when the PDMF production schedule allows. Ensures that all activities undertaken comply with cGMP and EH&S standards as detailed in relevant SOP’s and working practices. Authors and updates batch documentation, standard operating procedures and associated forms.

Responsible for the completion of quality related documentation, such as deviations, CAPA’s, protocols and change controls. The nature of the work requires the job holder to be flexible, with regards to working hours to ensure that they are available to complete a production process should it overrun. Trains and coaches new starters (re-train individuals) in Production manufacturing and packaging processes.

Looks for areas of improvement across all Production manufacturing…