Amgen

pharmaceutical

BioprocessTechnician

Dublin, Ireland; London, United Kingdom FULL TIME Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid+ candidates.

The Brief

“Bioprocess Technician at Amgen. Skills: Bioprocess Technician, Manufacturing, GMP, Problem solving, Continuous improvement. Set up of manufacturing equipment. Processing of parts and components for manufacturing”

What You'll Achieve.

Proven ability to deliver to personal, team and site objectives.

Industry & Context.

pharmaceutical
Problems you'll solve

Problem solving and troubleshooting; Excellent problem-solving skills

Eligibility Requirements

required to work a shift pattern

What They're Looking For.

Must Have

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., 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 area in Graded Aseptic Areas., 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

Nice to Have

A third level qualification in a relevant subject area, Aseptic experience preferred

What You'll Do.

Set up of manufacturing equipment

Processing of parts and components for manufacturing

Performing transactions in electronic systems such as EBR

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.

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

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.

testing and inspections as required.

How You'll Work.

Team & Collaboration

Support cross functional training across team members.; Team player with a demonstrated ability to work effectively with colleagues and peers in a cross functional environment

Communication Scope

Excellent communication skills; Fluent written and spoken English required

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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