Senior Principal: Lifecycle Validation & Tech Transfer

CSL Vifor; Bern; Vor Ort; CHF 150.000 - 190.000; Vollzeit

Zusammenfassung

CSL Behring in Bern, Switzerland seeks an experienced Senior Principal Engineer to lead lifecycle process validation across clinical and commercial manufacturing. You will drive risk-based strategies, oversee PPQ, technology transfers and CPV, and coordinate with CDMOs and internal teams across Europe.

You will influence senior stakeholders, mentor subteams, and ensure GMP-compliant validation documentation while navigating a matrix organization and supporting regulatory readiness.

Qualifikationen

• Bachelor's degree or higher in Chemical Engineering, Biotechnology, Pharmacy, Life Sciences or a related scientific or engineering discipline.
• Approximately 5-10 years of relevant experience within the pharmaceutical or biotechnology industry, with substantial experience in GMP-regulated manufacturing and process validation.
• Demonstrated experience developing and implementing validation strategies and supporting PPQ, lifecycle validation, technology transfer and process changes.
• Strong experience authoring and/or reviewing validation and comparability protocols, reports, risk assessments and related technical documentation.
• Experience working with CDMOs or other external manufacturing partners, with the confidence to establish expectations, challenge technical approaches and negotiate appropriate solutions.
• Experience supporting regulatory inspections, audits, regulatory documentation or health authority interactions.
• Working knowledge of quality risk management, statistical principles and lifecycle process validation expectations.
• Demonstrated technical leadership and ability to lead cross-functional or validation subteams and influence senior stakeholders without direct authority.
• Strong communication, negotiation and stakeholder-management skills, with the ability to communicate and defend complex technical strategies to different audiences.
• Ability to work effectively across functions, sites and time zones within a complex matrix organization while managing multiple projects and competing priorities.
• Fluent English is required; German language skills are an advantage but not required.
• Willingness to travel approximately 5-10% within Europe to support internal manufacturing sites, external partners and project activities.

Aufgaben

• 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, aligning validation requirements with project and product lifecycle plans.
• Provide technical leadership to validation subteams, mentor engineers and scientists and influence stakeholders across functions, sites and organizational levels while driving harmonization, knowledge sharing and continuous improvement of validation approaches and best practices.

Kenntnisse

Process validation

Lifecycle validation

Technology transfer

Regulatory inspections

Cross-functional leadership

Statistical principles

Ausbildung

Bachelor's degree or higher in Chemical Engineering, Biotechnology, Pharmacy, Life Sciences or related

Jobbeschreibung

CSL Behring in Bern, Switzerland seeks an experienced Senior Principal Engineer to lead lifecycle process validation across clinical and commercial manufacturing. You will drive risk-based strategies, oversee PPQ, technology transfers and CPV, and coordinate with CDMOs and internal teams across Europe.

You will influence senior stakeholders, mentor subteams, and ensure GMP-compliant validation documentation while navigating a matrix organization and supporting regulatory readiness.