BioMarin has a high-performing, team based organisation, where colleagues are flexible, multi-skilled and empowered to make decisions.
A high level of initiative, energy and motivation are key role requirements, as well as excellent organisational skills.
The Packaging Technician will serve as an integral member of CMO & Supply team in a biologics facility which incorporates drug substance manufacturing and labelling & packaging of finished product.
The ideal candidate will be able to demonstrate a proven track record in a quality-focused operational environment where attention to detail and commitment to the task at hand is key.
Reporting to the Packaging Specialist, and supported by the Packaging Equipment Technician, the successful candidate shall work as part of a team of Packaging Technicians to complete the packaging of Finished Product for onward distribution to patients.
The role entails operational activities within the new packaging suite at the Shanbally facility, with a focus on equipment operation and manual loading of packaging material and components to the line. For occasional packaging operations where the packaging line is not used, the Technicians responsibilities will consist of entirely manual activities to pack out the batch.
This candidate will be required to work closely within a cross-functional team including other Packaging Technicians, Packaging Equipment Technicians and representation from Quality, Material Operations (warehouse), Supply Chain and others.
This role requires flexibility with regards to work schedules and shift work may be required to support business needs
Main areas of responsibility:
• Operate the equipment on the new Packaging line within the Shanbally Packaging Suite.
• Fulfil the manual handling operations at the packaging line including
o Movement of vials to the line.
o Loading of packaging components/materials at the line (vial labels, cartons, leaflets, printer consumables, trays, shippers, pallets, tray & shipper labels, etc.) including ongoing replenishment.
o Manual insertion of vials and leaflets into automatically erected cartons at the equipment carousel.
o Manual loading of finished cartons into trays, trays into shippers, and shippers onto pallets.
o Removal of completed pallets from the operational space for onward movement to the cold store.
• For processes where the packaging line is not used, fulfil the above operations plus manual activities otherwise conducted by the equipment including vial label application, carton erection, vial and label insertion into cartons and loading of cartons/trays/shippers.
• Detailed batch record keeping (paper and electronic) which is accurate, attributable, complete, legible & clear, original, timely & prompt, and permanent.
• Identify issues on the line and alert the Packaging Equipment Technician. Provide support to the Packaging Equipment Technician to help resolve issues on the line as required.
• Conduct or assist with line clearances, packaging suite post batch cleaning and changeover.
• Support the packaging line commissioning and qualification team from FAT through SAT, IOQ, Characterisation and PQ as required.
• Demonstrate commitment to a high level of safety awareness within the packaging operations team.
• Proactively support continuous improvement and Lean initiatives within the packaging suite.
• Support investigations into Quality events, including reporting production issues, implementing CAPAs, etc. as required.
• Maintain an exemplary personal training record.
• Execute all operations activities in a safe manner and in strict accordance to SOPs, cGMP regulations and site Quality standards.
EDUCATION AND EXPERIENCE
• Previous experience in a highly regulated operating environment such as the biologics, pharmaceutical or medical device sectors is desirable though not essential. Previous packaging experience will be considered advantageous.
• Demonstrated experience (2+ years) of operating in a team environment (professional) is required.
• Candidates that can demonstrate a keen sense of focus and attention to detail when fulfilling exacting and repetitious tasks will have a distinct advantage.
• Must be conscientious and possess strong teamwork and interpersonal skills. Strong communication and problem solving skills are highly valued.
The Packaging Technician will be required to work closely within a cross-functional team including other Packaging Technicians, Packaging Equipment Technicians and representation from Quality, Material Operations (warehouse) and others.
Note: This description is not intended to be all-inclusive or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.