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Recently posted jobs
Biotech • Pharmaceutical
The Automation CSV Engineer supports validation, compliance, and testing for GMP automation systems, ensuring they remain compliant and operational. Responsibilities include documentation, testing, collaboration across teams, and maintaining regulatory standards.
Biotech • Pharmaceutical
The Quality Risk Manager ensures compliance with quality systems, manages site risk registers, coordinates risk assessments, and provides guidance on risk mitigation strategies.
Biotech • Pharmaceutical
Execute day-to-day QA activities for GMP manufacturing and maintain/enhance Quality Management Systems. Review and assess eQMS events (Deviations, CAPA, Change Control, etc.), support audits and inspections, deliver QMS training, monitor QMS effectiveness via metrics and trending, and collaborate with Manufacturing, Quality, and Facilities to ensure cGMP compliance and continuous improvement.
Biotech • Pharmaceutical
Lead global MSAT technology transfer and process validation for late-stage and commercial biologics. Drive site-to-site transfers, develop global templates/protocols (PPQ, PQ, batch records), perform gap/risk analyses and mitigation, analyze process data and annual reviews, support regulatory CMC documentation and inspections, and mentor junior engineers.
