Sterile Manufacturing Process Technician — Shift

Amgen SA; Ireland; Remote; EUR 40,000 - 60,000; Full time

Job summary

Amgen Dun Laoghaire is seeking a Manufacturing Process Technician–Inspection to join the sterile parenteral manufacturing team. You will report to the Shift Manager and contribute to equipment setup, GMP compliance, quality investigations and audits, and continuous improvement initiatives in a fast-paced, regulated environment.

The role requires hands-on manufacturing experience, strong problem-solving and communication skills, and fluency in English.

Qualifications

• Leaving Certificate standard or equivalent required.
• A third-level qualification in a relevant subject is preferred.
• Minimum 12 months experience in sterile pharmaceutical manufacturing or GMP environment.
• Knowledge of GMP principles and aseptic processing is beneficial.
• Experience with parenteral product manufacturing preferred.

Responsibilities

• Set up manufacturing equipment and clean and sanitize areas.
• Perform GMP-compliant manufacturing tasks and maintain records.
• Investigate deviations and document investigations.
• Participate in Quality & Safety Audits and internal inspections.
• Support audits by regulatory bodies (FDA/IMB) as needed.
• Contribute to MAP and cross-functional training programs.
• Maintain and review operational documentation and SOPs.
• Support development of manufacturing systems and continuous improvement.

Skills

Problem solving

Communication skills

Mechanical aptitude

Organizational skills

Team player

Fluent English

Education

Leaving Certificate or equivalent

Relevant third-level qualification

Tools

LIMS

Electronic Batch Records (EBR)

Job description

Amgen Dun Laoghaire is seeking a Manufacturing Process Technician–Inspection to join the sterile parenteral manufacturing team. You will report to the Shift Manager and contribute to equipment setup, GMP compliance, quality investigations and audits, and continuous improvement initiatives in a fast-paced, regulated environment.

The role requires hands-on manufacturing experience, strong problem-solving and communication skills, and fluency in English.