Beschreibung

As a Sr. Validation Engineer, you will engage in a variety of tasks, including preparing and approving critical validation documents and evaluating regulatory changes. This role involves collaborating with partners to define requalification strategies and ensuring compliance through audits and training programs.

Anforderungen

• •Bachelor’s degree in Biotechnology, Quality, Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or related field
• •10 years experience or Master's degree + 3 years in engineering field
• •Functional knowledge of cGMPs and manufacturing operations in FDA regulated facility
• •Experience in pharmaceutical industry for qualification & validation
• •Experience in multi-cultural work environment
• •Excellent verbal and written communication skills in English and preferably German or another European language
• •Strong understanding of GMP standards and regulatory requirements
• •Excellent technical writing skills with attention to detail
• •Proficiency in PC applications, including MS Office
• •Strong communication and interpersonal skills
• •Certification in technical writing or quality management
• •Experience with electronic documentation management systems (e.g., Documentum, TrackWise)

Aufgaben

• •Prepare, review, and approve production and validation documents
• •Evaluate new and existing regulations and regulatory trends
• •Prepare responses and reports for inspections and customer audits
• •Perform gap analysis to enhance efficiencies
• •Define requalification strategies for GMP systems with partners
• •Implement and maintain the quality system and practical activities
• •Coordinate activities executed by external contractors
• •Perform requalification and revalidation Work Orders
• •Document operations following Good Documentation Practices
• •Participate in continuous improvement and technology development
• •Identify training needs and develop training programs
• •Work safely to promote an injury-free workplace
• •Participate in calibration activities

Tools & Technologien