Ensuring that Amgen medicines reliably and safely reach “every patient, every time” is the charge of Amgen’s manufacturing organization. From the beginning, the company’s contributions to the emerging field of biotechnological production of human therapeutics have been driven by a strong commitment to meeting the needs of patients. From process development to clinical manufacturing and full-scale therapeutic protein production, the company has built one of the industry’s largest and most reliable operations.

•             More than 20 years of experience in bulk manufacturing

•             History of dependable supply of safe and effective therapies

•             Highly successful regulatory inspections

•             Best in class safety record

Amgen Dún Laoghaire (ADL)

• ADL is a 37,000 square metre aseptic operations facility, specialising in secondary manufacturing activities – formulation, fill and packaging. The ADL site also includes laboratories and cold chain warehouse capabilities.

• There is a strong culture of continuous improvement and innovation within the plant

• We are proud of our award-winning environmental sustainability programme

• Amgen is developing the capability to produce all of its medicines in Dun Laoghaire, helping to ensure continuity of supply of our medicines as we expand internationally

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.

Hiring Requirements

• Manufacturing Process, Packing and Inspections Technicians are required to work a variety of shift patterns examples including days, 2, 3 and 4 Rota shifts.
• The Manufacturing Process Technicians reporting to the shift manager, 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
• 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 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.

Basic Qualifications
• Educated to diploma level or equivalent in an appropriate discipline.
• Applicants should have relevant experience of operation of a manufacturing function in a sterile pharmaceutical manufacturing or similar environment.
• Be a results oriented person with excellent organizational, communicational 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 I&P equipment
• Good mechanical aptitude
• Excellent problem solving skills
• Ability to work in a team environment and on one’s own initiative