The Manufacturing Process Technician 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 Description Summary
The Manufacturing Process Technician reports to the Shift Manager and will be responsible for one or more roles relating to the manufacture and inspection of sterile parenteral drugs, including operating and setting up manufacturing equipment, processing parts and components, performing transactions in electronic systems, and cleaning and sanitizing production areas.
Main Responsibilities
* Monitor and adjust manufacturing processes to ensure high-quality products.
* Troubleshoot issues and implement solutions to prevent future problems.
* Ensure compliance with company policies and safety regulations.
Hiring Requirements
* Manufacturing Process Technicians must work a variety of shift patterns, including days, 2, 3, and 4 cycle shifts.
* Perform all operations with due care and attention, adhering to Good Manufacturing Practices and Amgen requirements.
* Involve in problem-solving and troubleshooting, including initiating and documenting investigations.
* Responsible for self-inspection Quality & Safety Audits within their functional area.
* Participate in a learning and development program, including annual reviews and goal setting via the Maximizing Amgen Performance (MAP) process.
* Responsible for cross-training other colleagues.
* Responsible for using, reviewing, revising, and upgrading operational documentation and peer review of operations.
* Play a key role in developing manufacturing systems and implementing continuous improvement initiatives.
* Identify operational improvement opportunities and process-related issues and escalate them to Senior Associate Tech Engineers for effective resolution and implementation.
* Champion safe working practices and safety initiatives within their functional area.
* Carry out sampling, testing, and inspections as required, as well as calibration and maintenance of test equipment.
* Contribute to corporate, FDA, HPRA audits, 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 operating 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.
* Good mechanical aptitude.
* Excellent problem-solving skills.