This is a key role in the achievement of Jazz business objectives for the Jazz Manufacturing facility. This role operates within a small cross-functional operations team and is integral to support routine commercial manufacture while complying with regulatory standards. The incumbent needs to be flexible, hard-working and prepared to carry-out the full remit of operator duties as well as technical responsibilities.

Essential Functions/Responsibilities

• Updating and writing of operational/maintenance SOP’s, and Batch Manufacturing Records.

• Assist in development of maintenance and calibration routines to ensure all manufacturing and utility equipment is maintained according to the manufacturer’s specifications.

• Perform preventative maintenance and calibration schedules on all manufacturing and service equipment as specified in the maintenance procedures.

• Manufacture, fill and package products as required by the business

• Complete Batch Records right first time

• Keep accurate records of calibrations / maintenance/ preventative maintenance and traceability.

• Accurately follow maintenance and production schedules

• Undertake further training as required to enhance skills.

• Collaborate with the Quality Control and Quality Assurance departments ensuring that all production, maintenance and calibration are in compliance with GMP directives.

• Lead the training, retraining and cross training of fellow Operations Technicians/Manufacturing Associates on the set up and operation of all machines and equipment.

• Proactively contribute to continuous improvement.

• Provide support for receipt of material from suppliers into the warehouse, including sampling and securing of said material.

• Provide support for shipment of product to various distributors

• Report to and be directed by the area manager.

Required Knowledge, Skills, and Abilities

• Strong understanding of Environmental, Health & Safety Requirements

• Strong understanding of Quality System Requirements

• Broad range of pharmaceutical manufacturing experience encompassing liquid and solid oral dose platforms along with filling and packaging processes.

• Experience of working in, and maintaining clean room conditions

• High degree of technical competence, including equipment fault troubleshooting skills

• Demonstrated capability in establishing collaborative working relationships at all levels

• Ability to develop and execute on maintenance and calibration routines

• Ability to accurately complete records associated with manufacturing, calibration and maintenance activities

• Foster a culture of change, innovation and self- improvement to maximise achievement of overall site goals

• Experience in the use of LIMS, Maximo/CMMS, Serialization, Scada Systems, PLC’s and SAP would be advantageous

Required/Preferred Education and Licenses

• Qualified Trade electrician or toolmaker preferred. Other relevant qualifications/experience will be considered

• Third level qualification in a relevant engineering or science discipline will be highly regarded

• Must be PC literate, with emphasis on Microsoft word and Microsoft Excel