Director - Site Validation

sible 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.

Key Responsibilities include:

• 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.

Basic Qualifications:

• Doctorate degree and 4 years of directly relevant experience or Master's degree and 8 years of directly related experience or 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.

Preferred Qualifications/Capabilities:

• 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 you can expect from us

As we work to develop treatments that take care of others, we also work to care for our staff's professional and personal growth and well-being. 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.

Join Us

If you're seeking a career where you can make a difference in the lives of patients while working alongside a high-performing team, we encourage you to apply.

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