Validation Manager – Medical Devices
TRIGA Consulting GmbH & Co. KG
full-time
Posted on:
Location Type: Hybrid
Location: Freiburg • Germany
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About the role
- Develop, maintain and advance validation management policies and procedures, including qualification, process validation, computerized system validation (CSV) and method validation
- Technically review, approve and support validation activities in development and production
- Train employees on validation-related topics
- Conduct internal audits and actively support inspections and external audits as a subject-matter expert
- Participate in CAPA management, including initiating, implementing and tracking corrective and preventive actions (CAPA)
Requirements
- Degree in engineering, natural sciences or a related technical field
- Several years of experience in qualification and validation within a GMP-regulated environment, e.g., pharmaceutical or medical device industries
- Fluent German (C1) and English skills
- Structured working style, strong documentation proficiency and a confident professional manner
Benefits
- Opportunity to shape processes in a stable, growth-oriented environment
- Flat hierarchies, short decision-making paths and collegial teamwork
- Flexible working hours with remote working option
- Competitive compensation, company pension plan and additional benefits such as Hansefit and bicycle leasing
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
validation managementqualificationprocess validationcomputerized system validationmethod validationCAPA managementinternal auditsdocumentation proficiency
Soft Skills
trainingstructured working stylestrong documentation proficiencyconfident professional manner