EXPERIENCE

• Applicants should have 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.

SKILLS

• Good mechanical aptitude
• Excellent problem-solving skills
• Excellent communication skills.
• Ability to work in a team environment and on one’s own initiative
• Experience working in Grade A/B area in Graded Aseptic Areas.
• Be a results-oriented person with excellent organization and team development skills with an ability to successfully interact with people, create a team environment and generate co-operation.

WHAT YOU WILL DO

Let’s do this. Let’s change the world. 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.
The Manufacturing Process Technician reports to the Shift Manager and will be responsible for one or more of several activities 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 Aseptic 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.

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.
Any other duty as may be designated by supervisor/ management from time to time.