Senior Principal Engineer - Process Validation & Transfer

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

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.