Senior Quality Engineer - Pharmaceutical or Medical Device

Job Description

Job Description

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)