Bioprocess Technician

Amgen; Dún Laoghaire; On-site; EUR 42,000 - 65,000; Full time

Job summary

Amgen Inc. seeks a Bioprocess Technician to support sterile parenteral drug manufacture in a dynamic Dublin site. You will set up equipment, ensure GMP compliance, and contribute to continuous improvement initiatives within a fast-paced environment.

The role requires a Leaving Certificate or equivalent, plus 12 months of sterile manufacturing experience or 2 years GMP exposure, with strong English communication and teamwork skills. A shift pattern is expected.

Qualifications

• Pass Leaving Certificate standard or equivalent.
• Minimum 12 months experience of operations within a sterile pharmaceutical manufacturing or 2 years in GMP/regulatory environment.
• Fluent written and spoken English.
• Experience working in Grade A/B aseptic areas; aseptic knowledge preferred.

Responsibilities

• Set up manufacturing equipment and process parts; perform transactions in systems like EBR and LIMS; clean and sanitize production areas.
• Operate in GMP environment following safety regulations and Amgen requirements.
• Troubleshoot and document investigations; participate in audits and quality checks.
• Support learning and development programs (MAP) and cross-functional training.
• Own use, review and update of operational documentation; contribute to manufacturing systems development.

Skills

Problem solving

Communication skills

Team player

Lean manufacturing

Mechanical aptitude

Right First Time

Education

Leaving Certificate

Third level qualification in relevant subject

Tools

Autoclaves

Filling lines

Formulation vessels

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

Let’s do this. Let’s change the world. In this vital role you will reportintothe Shift Manager. In this role, youwillhaveresponsibility foractivities relating to the manufacture of sterile parenteral drugs.

The Amgen Manufacturing Siteisa fast-paced and evolving environment,focused on continuous improvement of work processes and practices.Flexibility is key.You may be asked to carry outadditionalwork functions, associated with the role,asdesignatedby management,at times.

The successful candidate willbe requiredto work a shift pattern.

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.
• Performdutieswith due care andin accordance withGood Manufacturing Practices (GMP), Safety Regulationsand Amgen requirements.
• Problem solving and troubleshooting, including initiation and documentationof investigations.
• Performance of self-inspection during Quality & Safety Audits.
• SupportCorporate, FDA, IMB Auditors and other regulatory bodies during company audits.
• Participate in the learning and development programvia the Maximizing Amgen Performance (MAP) process.
• Support cross functional trainingacrossteammembers.
• 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
• Proactivelyidentifyoperational improvementand continuous improvementopportunitiesand / orprocess related issues including escalation & follow up for effective resolution and implementation.
• Champion safe working practices and safety initiatives.
• Sampling,testingand inspections asrequired.

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What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Bioprocess Technician professional we seek is an individual with these qualifications.

• Pass Leaving Certificate standard or equivalent-required
• A third level qualification in a relevantsubject area- preferred
• Minimum 12 months experience of operationswithina sterile pharmaceutical manufacturing or similar environmentORMinimum 2yearsof experience in a GMPand / orequivalentregulated environment.

• Demonstrated knowledge of GMP principlesandaseptic knowledgewithin GMP areas.Asepticexperience preferred.

• Drug productmanufacturing experience.

• Experience working with equipmentutilizedin the manufacture of parenteral products such as autoclaves, fillinglinesand formulation vessels.

• Demonstrated understanding and use of Right First Time (RFT) techniques and lean manufacturing concepts.

• Demonstratedmechanical aptitude

• Excellent problem-solvingand communicationskills

• Experience working in Grade A/B area in Graded Aseptic Areas.

• Proactive and results-focused withexcellentorganizational skills.

• Team player with a demonstrated ability towork effectively with colleagues and peers in a cross functional environment

• Provenability to deliver to personal, team and siteobjectives.

• Fluent written and spoken Englishrequired

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

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

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

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. Please contact us to request accommodation.