Company Description
Gerresheimer is an innovative systems and solutions provider for pharmaceutical primary packaging, drug delivery systems, medical devices and associated service, and as such a strategic partner for the global pharma and biotech industry.
www.gerresheimer.com
Job Description
We’re looking for a detail-oriented and driven Validation Engineer to lead the planning, coordination, and execution of validation and qualification activities for both production and support processes. This role is essential to maintaining our high standards in compliance, documentation, and risk management in line with global regulatory requirements.
Qualifications
Independently plan and execute validation and qualification activities across projects
Analyze test results, manage deviations, and evaluate changes impacting validated states
Prepare and maintain comprehensive documentation in compliance with ISO and FDA standards
Support internal and supplier audits, customer declarations, and requalification efforts
Collaborate cross-functionally to support regulatory and quality compliance initiatives
Contribute to continuous improvement in validation processes, documentation, and best practices
Lead or support risk management activities during project execution
Additional Information
Required Qualifications
Bachelor's degree in Mechanical Engineering, Industrial Engineering, or a related technical field
Minimum of 5 years' experience in quality assurance, qualification, and/or validation
Deep understanding of verification, validation, and regulatory standards
Technical Expertise
Solid knowledge of GMP, ISO 13485, ISO 14971, ISO 15378, MDR, and 21 CFR 820
Proficiency with digital systems including MES, ERP, Microsoft Office, Minitab, and quality management tools
Advanced knowledge of statistical and problem-solving methods (e.g., Kepner-Tregoe)
Skilled in project management principles and writing technical reports
Personal Competencies
Proactive, reliable, and flexible with a hands-on mindset
Strong interpersonal skills and emotional resilience
Excellent communication skills and ability to work well in cross-functional teams
Fluent in English (German is a plus)
