Senior Principal Engineer – Process Validation

CSL; Bern; Vor Ort; CHF 150.000 - 210.000; Vollzeit

Zusammenfassung

CSL Behring in Bern, Switzerland seeks a Senior Principal Engineer – Process Validation to lead lifecycle validation strategies across clinical and commercial manufacturing. You will guide PPQ planning, tech transfers and change management while maintaining validated state and collaborating with CDMOs and internal partners.

The role requires extensive GMP experience, strong leadership, and the ability to navigate a complex matrix, with 5–10% travel within Europe.

Qualifikationen

• Bachelor's degree or higher in a relevant science or engineering discipline.
• 5–10 years in GMP-regulated pharma/biotech manufacturing and process validation.
• Experience developing and implementing validation strategies and PPQ lifecycle validation.
• Experience authoring and reviewing validation protocols, reports and risk assessments.
• Experience with CDMOs or external manufacturing partners.
• Experience supporting regulatory inspections or health authority interactions.
• Knowledge of quality risk management, statistics and lifecycle validation expectations.
• Strong technical leadership to lead cross-functional validation subteams.
• Fluent English; German a plus; travel 5–10% within Europe.

Aufgaben

• Develop and implement risk-based lifecycle validation strategies aligned with regulatory expectations.
• Lead validation activities for new product introductions, tech transfers and network changes.
• Provide oversight for PPQ planning and execution and guide transition to CPV.
• Assess validation impact of changes to processes, equipment or networks and plan revalidation.
• Lead validation discussions with external partners and CDMOs; defend strategies with stakeholders.
• Review protocols, reports, deviations, risk assessments and CAPAs.
• Support regulatory submissions, inspections, audits and inspection readiness.
• Collaborate across MS&T, Manufacturing, Quality, Regulatory Affairs, Statistics and Supply Chain.
• Mentor validation subteams and influence stakeholders across sites and functions.

Kenntnisse

Cross-functional leadership

Communication

Negotiation

Stakeholder management

Leadership without authority

Ausbildung

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

Jobbeschreibung

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.

Responsibilities

• 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.

Qualifications

• 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.

About This Position

• This is a senior individual‑contributor and technical leadership position within our Validation, Data Analytics and Modeling organization. While the role has no direct reports, you will lead validation activities and subteams and act as a senior technical partner for colleagues, project teams, management and external manufacturing partners.
• You will work across both internal and CDMO projects within Europe, collaborating with local validation organizations and colleagues across multiple functions and locations. This requires the ability to navigate a matrix organization, accommodate collaboration across different time zones and build productive relationships with a broad range of technical and business stakeholders.
• A key aspect of the role is your ability to translate deep validation expertise into clear, scientifically justified strategies and confidently represent and defend these approaches with senior management and external partners. You will have significant autonomy in your area of expertise while contributing to reliable project execution, regulatory readiness and continued commercial supply.
• The position is based in Bern, Switzerland, with approximately 5–10% business travel within Europe.