Quality Engineering Manager

Quality Engineering Compliance Manager (M/W/D)

Tasks: • Review and Approve URSes, Quality Risk Assessments and Design Qualification • for a new Downstream Center for the Manufactue of chemically synthesized • Peptides, containing major equipment such as HPLCs, Freeze Drier, Spray Drier, • Cleanrooms Grade D and C, Utilities and process gases • Provide Input to URSes, Design Concepts and Documents from a Qualitybperspective and ensure Design meets intended purpose • Provide Input to Project Deviations and Project Change Controls as Quality Reviewer/Approver • Collaborate with cross-functional teams to ensure compliance with quality assurance standards meeting regulators and health authorities’ expectations • Ensure with /support global quality in qualifying Equipment suppliers and service providers

Qualifications: • Extensive experience In Quality Engineering (min 5 years), specifically related to compliance oversight of C&Q and CSV in CAPEX Projects • Experience in digital validation software ( Kneat) • Basic understanding of regulatory requirements, engineering standards and industry best practices (EU, PICS, ICH, FDA, ISPE, GAMP) • Excellent communication and interpersonal skills, strong, proactive “how can I help attitude” • German and English (business fluent)

Conditions: • Start: ASAP • Duration: 6 months • Workload: Full-time • Location: 4 days onsite (Stein) – 1 day remote