Senior Principal Engineer – Process Validation

CSL Behring, a worldwide leader in biotechnology dedicated to saving lives, is expanding its Validation, Data Analytics and Modeling (VDM) team at the Bern site. The senior role of Senior Principal Engineer, Process Validation will act as the technical authority for lifecycle validation of both clinical and commercial manufacturing processes, shaping risk‑based strategies that keep production in a validated state from start‑up through routine operation. The day‑to‑day work revolves around designing and executing validation plans for new product launches, technology transfers, and process modifications. You will guide Process Performance Qualification (PPQ) activities, define critical parameters and quality attributes, and oversee the shift to Continued Process Verification. The position also requires assessing the impact of changes to equipment, facilities or materials, leading re‑validation when needed, and reviewing validation documentation such as protocols, reports, risk assessments and deviation records. Interaction with internal sites and external Contract Development and Manufacturing Organizations (CDMOs) across Europe is essential, as is providing technical input for regulatory submissions and inspection readiness. Candidates must hold a bachelor's degree in engineering, biotechnology, pharmacy or a related life‑science discipline and bring 5–10 years of experience in the pharmaceutical or biotech sector, with a solid background in GMP‑regulated manufacturing and process validation. Proven ability to craft and apply validation strategies, manage PPQ programmes, and produce high‑quality technical documentation is required. Experience working alongside CDMOs, handling regulatory inspections or audits, and communicating fluently in English are also mandatory. The role demands strong leadership without direct line authority, excellent stakeholder‑management skills, and the flexibility to travel 5–10 % across Europe. The position offers a senior individual‑contributor role within a highly collaborative matrix environment, allowing you to influence cross‑functional teams, mentor engineers and scientists, and drive continuous improvement of validation practices. While German language skills are not compulsory, they are considered an advantage. The Bern location provides a modern biotech hub with access to a diverse, international workforce and the opportunity to contribute to life‑saving therapies for rare diseases. What the role asks for: - Bachelor's degree in Engineering, Biotechnology, Pharmacy or Life Sciences - 5–10 years pharma/biotech experience - GMP manufacturing and validation background with PPQ strategy experience - Experience collaborating with CDMOs or external partners - Experience handling regulatory inspections and audits - Fluent English communication - Willingness to travel 5–10 % across Europe - German language skills (nice‑to‑have)