Validation Engineer

Validation Engineer: Qualification / Validation / Auditing, / Quality functions MDR / ISO 13485 / 21 CFR 820 / External Manufacturing / Blow Molding / German / English

Background:
This is more than just a validation engineer position. You act as a reliable quality partner, auditor, supplier developer, technical expert and diplomat. As an expert in validation you will work together with our suppliers in qualification and validation projects. With your sound knowledge about quality regulations ( IVDR / MDR, ISO 13485, 21 CFR 820), qualification and validation, and various production technologies you will ensure that our high-quality products are manufactured in compliance with our standards and external regulations. Your main task is the supervision of qualification and validation activities with our suppliers. This encompasses process risk analyses, qualification and validation documentation and the corresponding documented evidence.
The Perfect Candidate holds a Bachelor's Degree in an engineering or scientific/technical field, or equivalent experience, supplemented by at least 10 years of professional background in quality functions like Q&V or auditing within the Pharma or medical device sectors. The candidate possesses over 5 years of experience in external manufacturing and holds a deep understanding of relevant standards and automated production technologies, such as injection and blow molding. Additionally, the individual demonstrates a consistent commitment to personal and team development, paired with professional-level communication skills in both English and German.

Tasks & Responsibilities:
• Review and evaluate qualification and validation documents and process risk analyses provided by our suppliers
• Oversee the assessment of deviations related to qualification and validation activities, ensuring they meet our rigorous standards
• Meticulously document the outcomes of your evaluations in compliance with established quality standards • Actively engage in the continuous improvement of processes, providing support in technical matters and performing statistical data analyses
• Offer expert advice to suppliers on quality and compliance, ensuring adherence to all relevant quality standards and specifications
• Thrive in cross-departmental collaboration, working effectively within squads to achieve common goals

Must Haves:
• A Bachelor's Degree in engineering, scientific/technical field, or equivalent work experience, with at least 10 years of related experience (Q&V, Auditing, or Quality functions) in Pharma or the medical device industry
• At least 5 years of experience with external manufacturing business
• Profound understanding of applicable standards and norms, along with expertise in injection molding, blow molding, or other automated production technologies
• Demonstrate a continuous desire for learning and improvement both for yourself and your team members
• Excellent communication skills in English and German (written and verbal)

Nice to Haves:
• Knowledge of computerized systems validation and controlled environment qualification (ISO 14644)
• Familiarity with product risk management according to ISO 14971
• Certified Lean Six Sigma Green Belt / Black Belt

Reference Nr.: 924946
Rolle: Validation Engineer
Industrie: Pharma
Location: Rotkreuz
Pensum: 80 - 100%
Start: Asap (
Duration: 12+ months
Deadline:

If this position has piqued your interest, please send us your complete resume. If this position does not quite match your profile and you would like to receive other positions directly, you can also send us your resume via this ad or to jobs[at]itcag[dot]com.
Contact us for more information about our company, our positions, or our attractive payroll-only program: .
About us:
ITech Consult is an ISO 9001:2015-certified Swiss company with offices in Germany and Ireland. ITech Consult specializes in placing highly qualified candidates for temporary staffing in the fields of IT, life sciences, and engineering. We offer temporary staffing and payroll services. This is free of charge for our candidates, and we do not charge any additional fees for payroll services.

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