Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 8,500 people from approximately 90 countries work in Basel, which is one of Roche`s largest sites.
Roche is an equal opportunity employer.
Process Validation Engineer (temporary 2 years)
Basel Biotech Manufacturing produces Biotech-APIs (Active Pharmaceutical Ingredients) for commercial and clinical supply. As the Process Validation Engineer, your key responsibilities are:
Develop and own process validation strategies: ensure compliance with PQS and health authority requirements. Represent validation program during HA inspections
Representation in process validation network teams
Lead/participate in process validation subteam in tech transfers
Work together with other process engineers, provide guidance
Write master and individual process validation protocols and reports
Plan, schedule and execute process validation studies, incl. shop floor support for sampling and ensure on-time completion of validation activities according to overall manufacturing schedule
Conduct training on validation for cGMP employees
Who you are
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
You have a University degree in a scientific or technical discipline, preferably in bioprocess or (bio-) chemical engineering. You demonstrate strong (intercultural) communication skills (with fluent German and English).
You bring the following qualifications:
Strong background in process validation within biotech manufacturing with knowledge of regulatory guidelines, health authority and cGMP (Good Manufacturing Practice) requirements and with at least 3 - 5 years of experience
Ability and willingness to coordinate technical teams assigned on a task / project basis
Ability to adapt to rapidly changing priorities and flexibility to support manufacturing operations