Bioprocess Technician

Bioprocess Technician

Amgen Dun Laoghaire

Live

What you will do

Let’sdo this.Let’schange the world. As part of Amgen’sOperationsOrganization,ourManufacturingFunctioncontinuously strives to be a differentiated leader in the manufacture of complex, high-quality therapeutics for our patients.

As a Bioprocess Technician, you willreportintothe 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.

Win

What we expect of you

Thesuccessful candidate for this role will bring the following education,skillsand experience

• Pass Leaving Certificate standard or equivalent-required

• A third level qualification in a relevant subject 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.Aspecticexperience 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