Medical Electronic jobs

Bioprocess Technician

Amgen Dun Laoghaire

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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 escalation & follow up for effective resolution and implementation.

• Champion safe working practices and safety initiatives.

• Sampling, testing and inspections as required.

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What we expect of you

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.

• 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 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