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Senior Process Engineer, Validation
JabilSenior Process Engineer in Validation at Jabil, focusing on compliance and validation in healthcare manufacturing. Collaborating with cross-functional teams to ensure quality and regulatory adherence.
About the role
Key responsibilities & impact- Responsible for creating, reviewing and executing validation documentation (IQ, OQ, PQ) in close collaboration with Quality Assurance and Production to ensure robust and compliant validation activities.
- Ensure that all process validation activities are carried out in accordance with the Quality Management System (QMS), applicable regulatory requirements and internal procedures.
- Responsible for evaluating and approving change requests with respect to validation impact to ensure the process validation status remains accurate and up to date.
- Support life-cycle activities for equipment and prepare the corresponding decommissioning documentation.
- Perform statistical analyses using statistical software such as Minitab.
- Actively support and participate in NPI projects (New Product Introduction) throughout the product lifecycle and prepare for and support internal and external audits (e.g., regulatory and customer audits).
- Support achievement of key business metrics by providing technical support for value stream processes.
- Cost management by executing projects in the areas of scrap, rework and consumables.
- Actively promote a culture of safety.
Requirements
What you’ll need- Bachelor's and/or Master's degree in a relevant engineering or scientific discipline or an equivalent combination of education and relevant work experience.
- Minimum of 5 years' professional experience in medical devices or a similarly regulated industry (e.g., pharmaceutical, biotechnology).
- Lean Six Sigma certification desirable.
- Excellent communication and presentation skills and strong problem-solving abilities.
- Extensive experience in validation methodologies as well as solid knowledge of statistical analysis tools and methods for data evaluation and process optimization.
- Fluent German and English required.
Benefits
Comp & perks- Professional development and a varied working environment
- A high degree of responsibility and opportunity for independent work
- A safe space for creative thinking and learning in the workplace
- Bonus scheme, additional vacation days and many other benefits
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
validation documentationIQOQPQstatistical analysisMinitabprocess validationdata evaluationprocess optimizationchange request evaluation
Soft Skills
communication skillspresentation skillsproblem-solving abilitiescollaborationsafety culture promotion
Certifications
Lean Six Sigma certification