Bioprocess Technician

Responsibilities

• Let's do this. Let's change the world. As part of Amgen's Operations O rganization, our Manufacturing Function continuously strives to be a differentiated leader in the manufacture of complex, high-quality therapeutics for our patients.
• As a Bioprocess Technician, you will report into the Shift Manager . In this role, you will have responsib ility for activities relating to the manufacture of sterile parenteral drugs .
• T he Amgen Manufacturing Site is a fast-paced and evolving environment , focused on continuous improvement of work processes and practices . Flexibility is key. Y ou may be asked to carry out additional work functions, associated with the role , as designated by management, at times.
• The successful candidate will be required to work a shift pattern.
• 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 troubleshootin g, including i nitiation and documentation of investigations.
• P erformance 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 .
• S ampling, testing and inspections as required .
• Win
• What we expect of you
• The successful candidate for this role will bring the following education, skills and experience
• P ass Leaving Certificate standard or equivalent - required
• A third level qualification in a relevant subject area - preferred
• Minimum 12 months e xperience 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 with in GMP areas. Aspectic 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 r esults- focused with excellent organizational skills.
• Team player with a demonstrated a bility 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
• Thrive
• What you can expect of us
• Amgen is an equal opportunities employer
• . Salary Range
• 39,477.40 EUR - 53,410.60 EUR

Benefits

Additional Information

Career Category Manufacturing Job Description Bioprocess Technician Amgen Dun Laoghaire Live

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