The Validation Department performs sterilisation validation activities to ensure compliance with company procedures, industry standards, regulatory expectations, and Amgen quality requirements in support of Operations and Quality Systems for primary and secondary Drug Product Manufacturing.
An opportunity has arisen for a Validation Engineer within the Aseptic Processing Validation team at Amgen Dún Laoghaire. This is a shift-based role operating 24/7 as needed to support business needs.
The APS Process Validation team perform validation and requalification activities for critical aseptic processing equipment and systems, including VPHP isolators, autoclaves, CIP/SIP systems, Lyophilisers, HVAC systems, and airflow visualisation studies. The team also provides validation oversight for aseptic process simulations (media fills) and requalification activities for critical manufacturing areas.
Validation Execution and Technical Support
Support Operations from a validation perspective to deliver, maintain, and sustain equipment in a qualified state in the most efficient and compliant manner possible.
Ensure validation approaches are based on the best available scientific evidence, sound professional judgment, and alignment with the broader Validation network.
Execute qualification and requalification testing in accordance with the Site Validation Master Plan, requalification plans, internal policies, procedures, and area-specific practices.
Technical Expertise:
VPHP Decontamination, Aeration Qualifications, Aseptic Filling Line Functional Testing (syringe and/or vial) and/or Aseptic Process Simulations
The successful candidate may work in any of these technical areas -for example supporting execution of the aseptic process simulation programme on a syringe or vial filling line with isolator or RABS technology, including aseptic intervention review, protocol and summary report preparation/ review, execution support, and MES hold-time support as directed by the manager
Quality Systems, Investigations, and Continuous Improvement
Provide validation support for Amgen’s quality management system, including change control, deviation, protocol discrepancy, and CAPA processes.
Assist with deviation and discrepancy investigations, including investigation write-up and supporting documentation.
Support continuous improvement initiatives that improve compliance, efficiency, and robustness of validation processes.
Collate, analyse, and report relevant validation data and metrics.
Documentation and Review Responsibilities
Write, implement, own, and approve changes to controlled documents, including SOPs, specifications, master protocols, and related validation documentation.
Review and approve protocols, reports, and data tables generated by staff and contract personnel.
Problem Solving, Collaboration, and Leadership Support
Apply strong judgment to resolve moderately complex problems where analysis of situations or data requires in-depth evaluation of multiple factors.
Make sound technical recommendations based on scientific evidence, compliance expectations, and operational needs.
Interact effectively with cross-functional peers, senior management, and other stakeholders on projects requiring negotiation and collaboration.
Support leadership in creating and implementing mid- to long-term departmental plans.
Ensure projects and routine work are executed safely, efficiently, and in accordance with applicable codes and Amgen standards.
Basic Qualifications
Master’s degree with at least 1 year of experience in Validation, Engineering, Microbiology, or Quality; or
Bachelor’s degree with at least 3 years of experience in Validation, Engineering, Microbiology, or Quality.
Technical Expertise
Understanding and application of validation principles, concepts, practices, and standards.
Knowledge of cGxP, regulatory expectations, and compliance requirements for biologics Drug Product manufacturing.
Working knowledge of sterilisation and decontamination systems, aseptic filling lines and relevant industry practices.
Experience with aseptic process simulation.
Communication, Collaboration, and Leadership
Excellent interpersonal, verbal, and written communication skills in a collaborative work environment.
Ability to express ideas clearly and present information effectively to Amgen leadership, internal teams, and external partners.
Demonstrated active listening, continuous feedback, and ability to facilitate problem solving, decision-making, and issue resolution.
Agility, Adaptability and Analytical Capability
Strong change management skills.
Ability to self-motivate or work as part of a team.
Comfortable working in a fast-paced, dynamic, and fluid environment under consultative direction toward predetermined long-range goals and objectives.
Ability to adjust workload based on changing priorities.
Ability to think critically and analyse data, with demonstrated troubleshooting skills.
