Bioprocess Technician Job at Amgen (Dun Laoghaire)

Job Description

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.

Job Responsibility

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

Requirements

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 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/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

Nice to have

A third level qualification in a relevant subject area
Aseptic experience

What we offer

Competitive salary structure
Generous Total Rewards Plan for staff and eligible dependents
Comprehensive employee benefits package, including retirement and savings plan with generous company contributions, group medical, life and disability insurance
Discretionary annual bonus program
Exceptional learning, development and career advancement opportunities

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