Aseptic Manufacturing Process Technician
As part of Amgen's Operations organization, Manufacturing continuously strives to be a differentiated leader in the manufacture of complex, high-quality therapeutics for our patients.
Key Responsibilities:
* Perform all operations with due care and attention and in accordance with Good Manufacturing Practices (GMP) and Amgen requirements.
* Problem solving and troubleshooting including initiation and documentation of investigations.
* Responsible for the performance of self-inspection during Quality & Safety Audits within their functional area.
* Contribute and assist with Corporate, FDA, IMB Auditors and other regulatory bodies during company audits.
* Participate in the learning and development program which will include annual reviews and goal setting via the Maximizing Amgen Performance (MAP) process.
* Support the team in cross functional training of other colleagues on the team.
* Ownership for the use, review, revision and upgrade of operational documentation and peer review of operations.
* Play a key role in the development of the manufacturing systems and will be responsible for continuous improvement initiatives.
* Proactively identify operational improvement opportunities or process related issues including escalation & follow up for effective resolution and implementation.
* Champion safe working practices and safety initiatives within their functional area.
* Carry out any sampling, testing and inspections as required of calibration and maintenance of test equipment.
Requirements:
* Educated to pass Leaving Certificate standard or equivalent (including Mathematics & English)
* A third level qualification in a relevant subject area would be an advantage.
* Relevant experience of operations of a manufacturing function in a sterile pharmaceutical manufacturing or similar environment.
* 2+ plus years of experience in a GMP/other regulated environment.
* Demonstrated knowledge of GMP principles.
* Demonstrated aseptic knowledge in GMP areas.
* Drug product manufacturing experience.
* Experience working with equipment utilized in the manufacture of parenteral products such as autoclaves, filling lines and formulation vessels.
* Demonstrated ability to deliver to personal, team and site objectives.
* Demonstrated understanding and use of Right First Time (RFT) techniques and lean manufacturing concepts.