Job Title:
Manufacturing Process Technician
Summary:
This role reports to the Shift Manager and involves responsibility for one or more roles relating to the manufacture of sterile parenteral drugs. Key responsibilities include operating and setting up manufacturing equipment, processing parts and components, performing transactions in electronic systems, and cleaning and sanitizing production areas.
Key Responsibilities:
* Perform operations with due care and attention, adhering to Good Manufacturing Practices and Amgen requirements.
* Be involved in problem-solving and troubleshooting, including documentation of investigations.
* Conduct 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.
* Be responsible for the use, review, revision, and upgrade of operational documentation and peer review of operations.
* Play a key role in developing manufacturing systems and contribute to continuous improvement initiatives.
* Champion safe working practices and safety initiatives within their functional area.
* Carry out sampling, testing, inspections, calibration, and maintenance of test equipment as required.
* Assist with corporate, FDA, IMB auditors, and other regulatory bodies during company audits.
Requirements:
* Educated to 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 of operation of a manufacturing function in a sterile pharmaceutical manufacturing or similar environment is essential.
* Results-oriented 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.
* Ability to work in a team environment and on one's own initiative.
Additional Requirements:
This is a Fixed Term Contract role for 24 months, and successful candidates will be required to work a shift pattern. Candidates must have previous aseptic experience.