Ingenieur Qualifizierung (m/w/d), HBS
Core
Qualifying ventilation systems, media systems, and cleanroom environments for biotechnological processes at a biopharmaceutical company.
Role type
Senior IC engineering specialist (GMP qualification)
Builds
Biopharmaceutical drugs and vaccines
Domain
Biotechnology / Pharma manufacturing
Required skills
GMP expertise, cleanroom qualification, risk analysis, CAPA management, change control, documentation, training
Preferred skills
MS Office, German (fluent), English (good)
Responsibilities
Create risk analyses and qualification test plans; Plan and execute qualifications including coordinating departments and service providers; Plan, create, and execute re-qualifications and periodic reviews; Provide technical control and acceptance of qualification activities and create documentation; Develop solutions and coordinate handling of deviations, CAPAs, and change controls; Present qualification reports during regulatory inspections and customer audits; Create/adjust standard operating procedures; Support and conduct training; Participate in cross-functional projects; Contribute to planning and implementation of company-specific quality goals
