Job Description Summary
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.
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, performs transactions in electronic systems, and cleans production areas.
* Works in compliance with company policies and safety regulations.
Hiring Requirements
1. Must work a variety of shift patterns including days, 2, 3 and 4 cycle shifts.
2. Performs all operations with due care and attention and in accordance with Good Manufacturing Practices and Amgen requirements.
3. Involved in problem solving and troubleshooting, initiation and documentation of investigations.
4. Responsible for self-inspection Quality & Safety Audits within functional area.
5. Part of a learning and development program, including annual reviews and goal setting via MAP process.
6. Responsible for cross-training of other colleagues, use, review, revision and upgrade of operational documentation.
7. Champions safe working practices and safety initiatives within functional area.
8. Carries out sampling, testing and inspections, calibration and maintenance of test equipment.
9. Contributes and assists with Corporate, FDA, HPRA Auditors and regulatory bodies during audits.
Qualifications
* Leaving Certificate standard or equivalent required (minimum five passes including English and Mathematics).
* Third level qualification in a relevant discipline would be an advantage.
* Relevant experience of 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.
* Good mechanical aptitude.
* Excellent problem-solving skills.