Manufacturing Process Technician

Amgen; Ireland; On-site; EUR 42,000 - 52,000; Full time

Benefits offered by this job

Competitive benefits

Job summary

Amgen is seeking a Manufacturing Process Technician at our Ireland site to join a fast-paced production team focused on sterile parenteral drugs. You will report to the Shift Manager and be responsible for set-up, operation, and sanitation of manufacturing equipment in a GMP environment.

The role requires 12 months of relevant operations experience or 2 years in a GMP-regulated setting, with strong attention to safety and documentation.

Qualifications

• Leaving Certificate standard required.
• A third level qualification in a relevant subject is preferred.
• Minimum 12 months in sterile pharmaceutical manufacturing or 2 years in GMP environments.
• Knowledge of GMP principles and aseptic practices; aseptic experience preferred.
• Experience with parenteral product manufacturing equipment is beneficial.
• Ability to work with an AI mindset and lean manufacturing concepts.
• Excellent problem-solving and communication skills; team player.

Responsibilities

• Set up manufacturing equipment and process parts for production with GMP compliance.
• Operate and sanitize production areas, and maintain documentation in electronic systems.
• Support audits by regulatory bodies and participate in continuous improvement efforts.
• Engage in cross-functional training and uphold safety initiatives.
• Identify operational improvements and ensure timely escalation and resolution.

Skills

GMP principles

Aseptic knowledge

Problem-solving

Communication skills

Teamwork

English fluent

Education

Leaving Certificate

Third level qualification in a relevant subject

Tools

Autoclaves

Filling lines

Formulation vessels

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.

Manufacturing Process Technician

What you will do

Let's do this. Let's change the world. As a Manufacturing Process Technician, you will report into the Shift Manager. In this role, you will have responsibility for activities relating to the manufacture of sterile parenteral drugs.

The Amgen Manufacturing Site is a fast-paced and evolving environment, focused on continuous improvement of work processes and practices. Flexibility is key. You may be asked to carry out additional work functions, associated with the role, as designated by management, at times.

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

We are all different, yet we all use our unique contributions to serve patients. The successful candidate for this role will bring the following education, skills and experience

• 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. Aspectic experience preferred.
• Drug product manufacturing experience.
• Demonstrated ability to work within an AI Mindset
• 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
• 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

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