Director - Site Validation Job at Amgen (Dun Laoghaire)

Job Description

At Amgen, our mission is to serve patients. At our Dun Laoghaire (ADL) site, we deliver life-changing medicines through advanced sterile fill-finish manufacturing. We are seeking a Director of Site Validation to lead a critical function supporting both commercial operations and significant site expansion. This role is a key member of the ADL Operating Team, as well as the Facilities & Engineering (F&E) Leadership Team and is accountable for leading the end-to-end Validation function. The successful candidate will provide strategic and technical leadership across validation lifecycle activities, ensuring compliance, inspection readiness, and operational excellence. The Director will lead a large, multidisciplinary organisation responsible for aseptic process simulation (media fills), cleaning and equipment validation, and ongoing lifecycle management. In addition, the Validation Director will play a pivotal leadership and oversight role in delivering commissioning and qualification (CQV) activities for major capital projects, including new syringe filling and inspection lines across multiple new facilities. This position requires strong strategic leadership, deep technical expertise in sterile manufacturing validation, and the ability to operate effectively in a highly matrixed, global organisation.

Job Responsibility

Strategic leadership for all site validation activities, ensuring alignment with Amgen global standards, regulatory requirements, and site objectives
Leading and developing a high-performing Validation organisation, setting clear expectations and fostering a culture of quality, compliance, accountability, and continuous improvement
Development of the organisation includes robust succession planning as well as a focus on how the function will support 24/7 operations e.g. via a new validation shift team
Owning all validation lifecycle activities including: Aseptic Process Simulations (media fills) strategy and execution
Airflow Visualisation Studies (AVS) and HVAC requalification programs
Sterilisation validation (VHP, autoclaves, SIP/CIP, lyophilisation)
Cleaning validation programs
Equipment validation
Facilities and Utilities
Effective continued process verification and lifecycle validation, including periodic review, requalification and data-driven performance monitoring programs
Ensures validation in accordance with cGMP (e.g., FDA, EMA, EU GMP Annex 1 regulations), maintaining inspection readiness at all times
Oversees commissioning and qualification (CQV) activities for major capital projects, including new syringe filling and inspection lines across ADL capital expansion programs (e.g. ADL1X and ADL2), ensuring successful project delivery in partnership with Global Engineering / Capital Projects
Establishes and maintains validation master plans (VMPs) and ensures execution against site and project timelines
Drives risk-based validation approaches and ensures effective application of science- and risk-based decision making
Ensures all validation activities are compliant with cGMP, regulatory expectations (FDA, EMA, HPRA), and Amgen standards
Partners closely with Manufacturing, Quality, Engineering, and Global Validation functions to ensure seamless integration of validation activities with site operations
Is the accountable compliance lead for F&E and leads deviation investigations, CAPA development, and regulatory responses related to validation activities
Provides leadership and direction in regulatory inspections and internal audits, representing Validation as a key function
Leads validation input to the site Contamination Control Strategy (CCS), ensuring alignment across HVAC, aseptic processing, cleaning and facility design
Provides validation leadership for technology transfers (particularly in relation to APS aspects) ensuring robust validation strategies and successful product introductions across existing and new manufacturing lines
Develops and manages departmental budgets, resource planning, and long-term capability strategies
Builds and sustains a high-performing organisation through coaching, mentoring, and talent development
Provides oversight of external validation partners and contract resources, ensuring quality, compliance and delivery against site objectives
Drives standardisation, simplification, and digitalisation initiatives within validation processes, as well as driving innovation & continuous improvement
Ensures effective communication of validation strategies, risks, and performance metrics to site and global stakeholders
Participates in Amgen global validation and manufacturing networks to share best practices and drive continuous improvement
Supports site labour relations and engagement within a unionised environment
Routinely reports progress against strategic goals, KPIs, and compliance metrics
Performs other leadership responsibilities as defined by the Site Head or Functional Leadership

Requirements

Doctorate degree and 4 years of directly relevant experience
Master’s degree and 8 years of directly related experience
Bachelor’s degree in Engineering, Life Sciences, or associated discipline and 10 years of directly related experience
Within experience must have 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, and programs or directing the allocation of resources
Extensive experience in validation within a sterile/aseptic manufacturing environment (fill-finish highly preferred)
Strong expertise in: Aseptic process simulation (media fills)
Cleaning validation
Equipment qualification and lifecycle management
Commissioning and qualification (CQV) for capital projects
Proven experience supporting large-scale capital project delivery and facility start-ups
Deep knowledge of cGMP regulations and regulatory expectations (FDA, EMA, HPRA)
Demonstrated ability to lead during regulatory inspections and audits
Strong leadership presence with the ability to influence across multiple levels of a global organisation
Strong strategic thinking and ability to translate strategy into execution
Excellent project and program management skills in a highly matrixed environment
Demonstrated ability to manage risk, make decisions under pressure, and prioritise effectively
Strong communication and stakeholder management skills
Proven ability to build, develop, and retain high-performing teams
Experience driving continuous improvement, operational excellence, and LEAN principles
High level of accountability with a commitment to delivering results in alignment with Amgen values

What we offer

Vast opportunities to learn and move up and across our global organisation
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan — including health, finance, and wealth benefits
Flexible work models, including remote and hybrid work arrangements, where possible

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