Amgen
Manufacturing
BioprocessTechnician
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Bioprocess Technician at Amgen. Skills: process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement. Set up manufacturing equipment. processing of parts and components”
What You'll Achieve.
deliver to personal, team and site objectives
Industry & Context.
Problem solving and troubleshooting; Excellent problem-solving skills; process related issues including escalation & follow up for effective resolution
work a shift pattern, Flexibility is key, may be asked to carry out additional work functions
What They're Looking For.
Must Have
Pass Leaving Certificate standard or equivalent, 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, 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, Demonstrated mechanical aptitude, Excellent problem-solving and communication skills, Experience working in Grade A area in Graded Aseptic Areas, Proactive and results-focused with excellent organizational skills, Proven ability to deliver to personal, team and site objectives, Fluent written and spoken English required
Nice to Have
A third level qualification in a relevant subject area, aseptic knowledge within GMP areas, Aspectic experience preferred, lean manufacturing concepts, Team player with a demonstrated ability to work effectively with colleagues and peers in a cross functional environment
What You'll Do.
Set up manufacturing equipment
processing of parts and components
performing transactions in electronic systems
cleaning and sanitization of production areas
Perform duties with due care
Problem solving and troubleshooting
initiation and documentation of investigations
Performance of self-inspection during audits
Support regulatory bodies during audits
Participate in learning and development program
Support cross functional training
Ownership for operational documentation
peer review of operations
development of manufacturing systems
identify operational improvement opportunities
process related issues escalation
effective resolution and implementation
Champion safe working practices
testing and inspections
How You'll Work.
Team & Collaboration
Support cross functional training across team members; work effectively with colleagues and peers in a cross functional environment
Communication Scope
Excellent communication skills; Fluent written and spoken English
Full Job Description
## **Career Category** Manufacturing ## ## **Job Description** **Bioprocess Technician** **Amgen Dun Laoghaire** **Live** **What you will do** Let’s do this. Let’s change the world. As part of Amgen’s Operations Organization, 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 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. The successful candidate will be required to 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. * 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
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