Job Description Summary
The Manufacturing Process Technician at Amgen plays a crucial role in the operation and maintenance of manufacturing equipment. This individual is responsible for monitoring and adjusting manufacturing processes, troubleshooting any issues, and ensuring the quality of final products. They work in compliance with company policies and safety regulations.
Job Responsibilities:
* Reports to the Shift Manager and responsible for one or more roles relating to the manufacture and inspection of sterile parenteral drugs.
* Operates and sets up manufacturing equipment, processes parts and components for manufacturing, performs transactions in electronic systems, and cleans and sanitizes production areas.
* Works a variety of shift patterns including days, 2, 3, and 4-cycle shifts.
* Performs all operations with due care and attention and in accordance with Good Manufacturing Practices and Amgen requirements.
* Involved in problem-solving and troubleshooting, including initiation and documentation of investigations.
* Responsible for self-inspection Quality & Safety Audits within their functional area.
* Part of a learning and development program that includes annual reviews and goal setting via the Maximizing Amgen Performance (MAP) process.
* Cross-trains other colleagues, uses, reviews, revises, and upgrades operational documentation, and peer-reviews operations.
* Develops manufacturing systems and participates in continuous improvement initiatives.
* Champions safe working practices and safety initiatives within their functional area.
* Carries out sampling, testing, and inspections, as well as calibration and maintenance of test equipment.
* Assists with Corporate, FDA, HPRA Auditors, and other regulatory bodies during company audits.
Qualifications:
* 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.
* Relevant experience in the operation of a manufacturing function in a sterile pharmaceutical manufacturing or similar environment.
* Results-oriented person with excellent organization, communication, and team development skills.
* 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 utilized in the manufacture of parenteral products such as Automated Visual Inspection, filling lines, formulation vessels.
* Good mechanical aptitude.
* Excellent problem-solving skills.
* Ability to work in a team environment and on one's own initiative.