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Aseptic Manufacturing Process Technician

2 months ago

Dublin, Dublin City, Ireland Amgen Full time

The Manufacturing Process Technician reports to the Shift Manager and will be responsible for one or more of a number of roles relating to the manufacture of sterile parenteral drugs to include but not limited to operation and set up of manufacturing equipment, processing of parts and components for manufacturing, performing transactions in electronic systems such as EBR, LIMS, SAP etc. and cleaning and sanitization of production areas.

This job specification outlines the general responsibilities associated with the role of Manufacturing Process Technician on the Amgen Manufacturing Site. The site is focused on continuous improvement of all work processes and practices and all colleagues are required to be flexible in this regard. This means that they may be asked to carry out additional work functions that are not described in this specification but are associated with their role.

Please note this is a Fixed Term Contract role for 24 months and successful candidates will be required to work a shift pattern. Candidates must have previous aseptic experience.

Hiring Requirements:


• Manufacturing Process, Packing and Inspection Technicians are required to work a variety of shift patterns including days, 2, 3 and 4 cycle shifts.


• They will perform all operations with due care and attention and in accordance with Good Manufacturing Practices and Amgen requirements.


• They will be involved in problem solving and troubleshooting including initiation and documentation of investigations.


• They will be responsible for the performance of self-inspection Quality & Safety Audits within their functional area.


• They will be part of a learning and development program which will include annual reviews and goal setting via the Maximizing Amgen Performance (MAP) process. They will be responsible for the cross training of other colleagues.


• They will be responsible for the use, review, revision and upgrade of operational documentation and peer review of operations.


• They will play a key role in the development of the manufacturing systems and will be responsible for continuous improvement initiatives. Proactively identifying operational improvement opportunities or process related issues including escalation & follow up with area Sr. Associate Tech Engineers for effective resolution and implementation.


• They will be champions for safe working practices and safety initiatives within their functional area.


• They will carry out any sampling, testing and inspections that may be required. They will also carry out calibration and maintenance of test equipment.


• Contribute and assist with Corporate, FDA, IMB Auditors and other regulatory bodies during company audits.


• They will carry out any other duty as may be designated by supervisor/ management from time to time.

Qualifications:


• Educated to Leaving Certificate standard or equivalent (minimum five passes including English and Mathematics required).


• A third level qualification in a relevant discipline would be an advantage.


• Applicants should have some relevant experience of operation of a manufacturing function in a sterile pharmaceutical manufacturing or similar environment.


• Be a results-oriented person with excellent organization, communication and team development skills with an ability to successfully interact with people, create a team environment and generate co-operation.


• Demonstrated ability to deliver to team, site and personal objectives.


• Demonstrated understanding and use of RFT techniques and lean manufacturing concepts.

Preferred Skills:

Experience working with equipment utilised in the manufacture of parenteral products such as autoclaves, filling lines, formulation vessels plus:


•Good mechanical aptitude


•Excellent problem-solving skills


•Ability to work in a team environment and on one's own initiative


•Experience working in Grade A/B area.