Bioprocess Technician

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

Career Category Manufacturing Job Description Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Bioprocess Technician

What you will do

Key Responsibilities

• Set up of manufacturing equipment, processing of parts and components for manufacturing, performing transactions in electronic systems such as EBR, LIMS, etc. and cleaning and sanitization of production areas.
• Perform duties with due care and in accordance with Good Manufacturing Practices (GMP), Safety Regulations and Amgen requirements.
• Problem solving and troubleshooting, including initiation and documentation of investigations.
• Performance of self-inspection during Quality & Safety Audits.
• Support Corporate, FDA, IMB Auditors and other regulatory bodies during company audits.
• Participate in the learning and development program via the Maximizing Amgen Performance (MAP) process.
• Support cross functional training across team members.
• Ownership for the use, review, revision and upgrade of operational documentation and peer review of operations.
• Play a key role in the development of manufacturing systems Proactively identify operational improvement and continuous improvement opportunities and / or process related issues including escalation & follow up for effective resolution and implementation.
• Champion safe working practices and safety initiatives.
• Sampling, testing and inspections as required.

What we expect of you

• Pass Leaving Certificate standard or equivalent - required
• A third level qualification in a relevant subject area - preferred
• Minimum 12 months experience of operations within a sterile pharmaceutical manufacturing or similar environment OR Minimum 2 years of experience in a GMP and / or equivalent regulated environment.
• Demonstrated knowledge of GMP principles and aseptic knowledge within GMP areas.
• Aseptic experience preferred.
• Drug product manufacturing experience.
• Experience working with equipment utilized in the manufacture of parenteral products such as autoclaves, filling lines and formulation vessels.
• Demonstrated understanding and use of Right First Time (RFT) techniques and lean manufacturing concepts.
• Demonstrated mechanical aptitude
• Excellent problem-solving and communication skills
• Experience working in Grade A/B area in Graded Aseptic Areas.
• Proactive and results-focused with excellent organizational skills.
• Team player with a demonstrated ability to work effectively with colleagues and peers in a cross functional environment
• Proven ability to deliver to personal, team and site objectives.
• Fluent written and spoken English required

What you can expect of us

In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Salary Range

39,477.40 EUR - 53,410.60 EUR

Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law. We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen