Sterile Bioprocess Technician - GMP Manufacturing

1061 Amgen Technology (Ireland) UC; Dublin; On-site; EUR 39,000 - 53,000; Full time

Job summary

Amgen Inc. in Ireland is seeking a Bioprocess Technician to join our manufacturing team. You will support sterile pharmaceutical operations, from setup of equipment to cleaning and documentation, ensuring GMP compliance and safety standards.

The role emphasizes problem solving, maintenance of operational docs, and participation in training programs like MAP. Fluency in English is required, and prior aseptic experience is valued. Competitive base salary is offered along with Total Rewards.

Qualifications

• Pass Leaving Certificate or equivalent.
• A third level qualification in a relevant subject area preferred.
• Minimum 12 months experience of operations within a sterile pharmaceutical manufacturing or 2 years of GMP/regulatory environment.
• Demonstrated knowledge of GMP principles and aseptic knowledge within GMP areas.
• Aseptic experience preferred.
• Drug product manufacturing experience.
• Experience with equipment used in parenteral manufacturing (autoclaves, filling lines, vessels).
• Understanding and use of Right First Time (RFT) techniques and lean manufacturing concepts.
• Demonstrated mechanical aptitude.
• Excellent problem-solving and communication skills.
• Experience in Grade A/B aseptic areas.
• Proactive and results-focused with strong organizational skills.

Responsibilities

• Set up manufacturing equipment and process parts; perform transactions in EBR, LIMS, etc. and clean/sanitize production areas.
• Perform duties per GMP, safety regulations and Amgen requirements.
• Problem solving and investigations, including documentation.
• Self-inspection during Quality & Safety Audits.
• Support audits by Corporate, FDA, IMB and other regulatory bodies.
• Participate in the MAP development program.
• Support cross-functional training across team members.
• Own use, review, revision and upgrade of operational documentation and peer review of operations.
• Identify opportunities for operational improvement and escalate issues for resolution and implementation.
• Champion safe working practices and safety initiatives.
• Sampling, testing and inspections as required.

Skills

GMP principles

Aseptic knowledge

Problem solving

Communication skills

Team player

English fluency

RFT techniques

Lean manufacturing

Mechanical aptitude

Education

Leaving Certificate

Third level qualification

Job description

Amgen Inc. in Ireland is seeking a Bioprocess Technician to join our manufacturing team. You will support sterile pharmaceutical operations, from setup of equipment to cleaning and documentation, ensuring GMP compliance and safety standards.

The role emphasizes problem solving, maintenance of operational docs, and participation in training programs like MAP. Fluency in English is required, and prior aseptic experience is valued. Competitive base salary is offered along with Total Rewards.