Validation Engineer (Shift Role)

Role Overview

The Validation Engineer will join the Aseptic Processing Validation team at Amgen in Dún Laoghaire, operating on a shift basis to support the sterilization validation and qualification activities for drug product manufacturing. This role is critical to ensuring compliance with company procedures, industry standards, and regulatory requirements.

Key Responsibilities

• Deliver and sustain qualified aseptic processing equipment and systems in support of operations while ensuring efficient and compliant operations.
• Perform validation and requalification testing aligned with the Site Validation Master Plan and internal policies, covering VPHP isolators, autoclaves, CIP/SIP systems, lyophilizers, HVAC, and airflow visualization studies.
• Support aseptic process simulations (media fills) and critical manufacturing area requalification activities.
• Provide technical expertise related to VPHP decontamination, aeration qualifications, and aseptic filling line functional tests for syringes or vials.
• Contribute to quality systems by supporting change control, deviation and CAPA processes, preparing investigation reports, and driving continuous improvement initiatives.
• Develop, review, and approve controlled documents such as SOPs, master protocols, and validation reports.
• Resolve moderately complex problems through sound technical judgment and collaboration across functional teams and management.
• Support leadership in strategic planning and ensure safe, efficient execution of projects as per Amgen standards.

Qualifications and Experience

• Master's degree with minimum 1 year or Bachelor’s degree with at least 3 years’ experience in Validation, Engineering, Microbiology, or Quality.
• Strong understanding of validation concepts, regulatory expectations, cGxP compliance, and biologics drug product manufacturing.
• Experience with sterilization/decontamination systems and aseptic filling line operations, including aseptic process simulations.
• Excellent verbal and written communication skills with ability to collaborate and present effectively to diverse stakeholders.
• Demonstrated skills in problem solving, change management, adaptability, and analytical thinking in fast-paced environments.

Additional Information

This position operates across shift patterns to meet 24/7 business needs. Candidates must be comfortable working flexible hours and collaborating across multiple teams to ensure quality and compliance in aseptic drug manufacturing processes.