The successful candidate will work closely with Engineering System Owners, Quality, Operations, Maintenance, Automation, Project Management and external delivery partners. The role will provide validation governance for assigned utilities, including inspection readiness, validation change assessments, development of user requirements and quality risk assessments, and definition of appropriate risk-based qualification approaches.
What you will do
Key Responsibilities
Provide technical validation support for assigned utility systems across the full lifecycle from initial design through commissioning, qualification, handover and validation maintenance.
Act as the Validation lead for assigned utility systems and projects, working in partnership with the Engineering System Owner and relevant cross-functional stakeholders.
Lead or approve validation impact assessments for changes to utility systems,
Determine the validation deliverables and level of qualification required based on system classification, intended use, change complexity and risk.
Lead the development, review and approval of User Requirement Specifications (URS) and Quality Risk Assessments for Equipment and Automated Systems (QRAES).
Develop and approve risk-based commissioning and qualification approaches, including use of prior knowledge, vendor documentation, equivalency or family strategies, bracketing, worst-case selection and leveraged testing where justified.
Develop, review or approve C&Q plans, validation plans, test strategies, FAT, SAT, installation verification, functional testing, qualification summary reports and other qualification activities, as applicable.
Ensure qualification requirements and acceptance criteria are clear, traceable and aligned with approved requirements and identified critical aspects.
Provide technical oversight during qualification execution, including readiness reviews, field / walkdown support, assessment of exceptions or test failures and confirmation of appropriate corrective actions.
Ensure validation commitments within change controls are clear, proportionate, appropriately sequenced and supported by suitable closure evidence, to ensure utility systems remain in a validated state.
Support the handover of utility systems to operational ownership, ensuring validation prerequisites, qualification records and lifecycle requirements are complete and appropriately controlled.
Maintain assigned validation records in a state of inspection readiness and support internal audits, regulatory inspections, regulatory filings and responses to questions.
Provide validation support for deviations, discrepancies, CAPAs and investigations that may affect utility systems or the qualified state.
Identify validation compliance or lifecycle gaps and lead or support practical remediation actions with Engineering System Owners and Quality.
Update and maintain validation procedures, guidance and standard work in accordance with site and corporate requirements.
Support continuous improvement of the validation lifecycle process using lessons learned, metrics, recurring issues and current industry practice.
Provide technical guidance and coaching to engineers, contractors and project teams on risk-based validation and documentation expectations.
Plan and coordinate validation activities, priorities, dependencies and deliverables across multiple projects and operational needs.
Take ownership for quality and compliance in assigned activities and escalate significant risks to the qualified state in a timely manner.
Utilities Scope
The role may support clean and plant utilities supplying clean utilities and their associated distribution systems, controls, instrumentation and interfaces. Utility systems may include purified water, water for injection, clean steam, process gases (compressed air, nitrogen), and their automation interfaces.
What we expect of you
Education / Experience
Master’s degree in Engineering, Science or a related technical discipline with at least 3 years of relevant Validation, Commissioning and Qualification, Engineering or Quality experience; or a Bachelor’s degree with at least 5 years of relevant experience.
Demonstrated experience working in a cGMP pharmaceutical or biotechnology manufacturing environment.
Experience in the qualification and lifecycle management of GMP utility systems, preferably within sterile drug product, biologics or a comparable regulated manufacturing environment.
Strong understanding of risk-based commissioning and qualification and the application of validation lifecycle principles.
Demonstrated experience developing or reviewing URS, QRAES, validation impact assessments, qualification strategies, protocols, reports and traceability documentation.
Experience assessing system changes and interfaces involving automation, instrumentation, calibration, maintenance, sampling or monitoring.
Experience supporting regulatory inspections, internal audits or inspection-readiness activities is preferred.
Strong technical judgment and problem-solving capability, with the ability to make clear and defensible recommendations in complex situations.
Ability to manage multiple priorities, work independently and influence cross-functional stakeholders without direct authority.
Excellent written and verbal communication skills and the ability to provide technical direction to engineers, contractors and project teams.
Knowledge of applicable safety, GMP, data integrity and environmental regulatory requirements.
Role clarification: This is a senior individual contributor position. This role provides Validation ownership of the qualification strategy, validation impact assessment and evidence supporting the qualified state.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.
We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation.
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- Salary Range
- 74,291.70 EUR - 100,512.30 EUR
