Aseptic Manufacturing Process Technician

Overview

Aseptic Manufacturing Process Technician – Amgen Dun Laoghaire

Live

Let's do this. Let's change the world. As part of Amgen's Operations organization, Manufacturing continuously strives to be a differentiated leader in the manufacture of complex, high-quality therapeutics for our patients.

What You Will Do

The Manufacturing Process Technician reports to the Shift Manager and will be responsible for one or more activities relating to the manufacture of sterile parenteral drugs, including but not limited to:

• Operation and set up of manufacturing equipment
• Processing of parts and components for manufacturing
• Performing transactions in electronic systems such as EBR, LIMS, SAP
• Cleaning and sanitization of production areas

This role supports continuous improvement across work processes and practices. Colleagues may be asked to carry out additional duties related to their role.

Please note that successful candidates will be required to work a shift pattern. Candidates must have previous aseptic experience and speak fluent English.

Responsibilities

• Perform all operations with due care and in accordance with GMP and Amgen requirements
• Problem solving and troubleshooting including initiation and documentation of investigations
• Self-inspection during Quality & Safety Audits within their functional area
• Assist with Corporate, FDA, IMB Audits and other regulatory body audits
• Participate in learning and development program via the Maximizing Amgen Performance (MAP) process
• Support cross-functional training of colleagues
• Own the use, review, revision and upgrade of operational documentation and peer review
• Contribute to development of manufacturing systems and continuous improvement initiatives
• Identify operational improvement opportunities, escalate as needed, and follow up for effective resolution
• Champion safe working practices and safety initiatives
• Carry out sampling, testing and inspections as required for calibration and maintenance of test equipment
• Any other duty as designated by supervisor/management

What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. The Manufacturing Process Technician is an individual contributor with these qualifications.

• Educated to pass Leaving Certificate standard or equivalent (including Mathematics & English)
• A third level qualification in a relevant subject area would be an advantage

Experience

• Relevant experience of operations of a manufacturing function in a sterile pharmaceutical manufacturing or similar environment
• 2+ years of experience in a GMP/regulated environment
• Demonstrated knowledge of GMP principles
• Demonstrated aseptic knowledge in GMP areas
• Drug product manufacturing experience
• Experience with equipment used in the manufacture of parenteral products (e.g., autoclaves, filling lines, formulation vessels)
• Ability to deliver to personal, team and site objectives
• Understanding and use of Right First Time (RFT) techniques and lean manufacturing concepts

Skills

• Good mechanical aptitude
• Excellent problem-solving skills
• Excellent communication skills
• Ability to work in a team and on one's own initiative
• Experience in Grade A/B areas in graded aseptic environments
• Results-oriented with strong organization and team development abilities

ThriveWhat You Can Expect Of Us

We support professional and personal growth and well-being. In addition to base salary, Amgen offers a Total Rewards Plan including:

• Comprehensive employee benefits package including retirement and savings, group medical, life and disability insurance
• A discretionary annual bonus program

Seniorities

• Seniority level
• Not Applicable

Employment type

• Full-time

Job function

• Manufacturing

Industries

• Biotechnology Research and Pharmaceutical Manufacturing

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