Validation Engineer (Shift) at Amgen

Location: Dún Laoghaire
Type: Full-time
Level: mid

Description

Amgen is hiring a shift-based Validation Engineer for the Aseptic Processing Validation team at its Dún Laoghaire site. The role supports 24/7 operations as needed and focuses on validation and requalification of critical aseptic processing equipment and systems, aseptic process simulations, quality system support, documentation ownership, investigations, and continuous improvement in a regulated biologics drug product manufacturing environment.

Required Skills

Validation
Aseptic processing
Media fills
CAPA
Data analysis
Technical writing

Additional Information

Minimum Education: Master’s degree in Validation, Engineering, Microbiology, or Quality with at least 1 year of experience, or bachelor’s degree in Validation, Engineering, Microbiology, or Quality with at least 3 years of experience
Required Previous Experiences: 1+ year of experience in Validation, Engineering, Microbiology, or Quality
3+ years of experience in Validation, Engineering, Microbiology, or Quality
Preferred Qualifications: Strong understanding of validation principles and standards
Knowledge of cGxP and biologics drug product compliance requirements
Working knowledge of sterilization, decontamination systems, and aseptic filling lines
Experience with aseptic process simulation
Strong communication skills
Strong change management skills
Critical thinking and troubleshooting skills

About Amgen

Amgen

life-saving medicinesThousand Oaks, California

Amgen discovers, develops, manufactures and delivers innovative medicines to fight some of the world’s toughest diseases. Harnessing the best of biology and technology, Amgen reaches millions of patients with its medicines, helping make people’s lives easier, fuller and longer.