Senior Principal Engineer - Process Validation

Innovative and committed to patients worldwide. CSL Behring is a global biotechnology leader, driven by its promise to save lives. At our site in Bern, we develop and manufacture life-saving therapies for people with serious and rare diseases around the world.

For our Validation, Data Analytics and Modeling (VDM) team within Technical Operations, we are looking for an experienced validation professional to join us as Senior Principal Engineer - Process Validation (100%) (m/f/d). In this senior technical expert role, you will provide leadership and subject matter expertise for lifecycle process validation across clinical and commercial manufacturing. You will develop and implement scientifically sound, risk-based validation strategies and ensure that manufacturing processes perform as intended and remain in a validated state throughout their lifecycle.

Working across internal manufacturing sites and external partners, including Contract Development and Manufacturing Organizations (CDMOs) across Europe
, you will play a key role in process validation, technology transfers, process changes and manufacturing readiness. You will operate in a highly collaborative matrix environment, leading validation activities and subteams without direct reporting responsibility and influencing technical teams, external partners and senior stakeholders.

• Develop and implement scientifically sound, risk-based lifecycle process validation strategies aligned with applicable regulatory expectations and CSL standards, providing senior technical expertise for complex and non-routine validation topics.
• Lead validation activities supporting new product introductions, technology transfers, process and network changes and lifecycle management, including the development of fit-for-purpose validation and comparability strategies, protocols, acceptance criteria and technical justifications.
• Provide technical oversight for Process Performance Qualification (PPQ) planning and execution, ensuring appropriate consideration of process knowledge, critical process parameters, critical quality attributes, control strategies, sampling and statistical principles, and guide the transition to Continued Process Verification (CPV).
• Assess the validation impact of changes to processes, equipment, facilities, materials and manufacturing networks, developing appropriate revalidation approaches and supporting implementation while maintaining the validated state.
• Provide validation leadership for internal and external technology transfers, scale-up and manufacturing readiness activities, establishing clear validation expectations and reviewing documentation developed by manufacturing sites, CDMOs, laboratories and other service providers.
• Lead technical validation discussions with external partners and CDMOs, constructively challenging approaches where appropriate and developing, communicating and defending validation strategies and recommendations with external partners, project governance and senior management.
• Review and approve validation protocols, reports, deviations, risk assessments and conclusions, and support investigations of validation failures or atypical results, including the definition and follow-through of appropriate CAPAs.
• Provide validation expertise for regulatory submissions, health authority inspections, internal audits and inspection-readiness activities, ensuring validation approaches and documentation are aligned with applicable GMP requirements and regulatory expectations.
• Collaborate across a complex matrix organization with local validation teams and functions including MS&T, Manufacturing, Quality, Regulatory Affairs, Process Development, Statistics, CPV, Supply Chain and Technology Transfer,…