Senior Requalification Engineer(m/w/x)

Anforderungen

• Adherence to GMP Safety Standards
• Cleanroom adherence (no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair)
• Use of PPE (safety glasses, gowning, gloves, lab coat, ear plugs)
• Bachelor’s degree in Biotechnology, Quality, Mechanical, Manufacturing, Industrial Engineering, or related field
• 10 years experience with Bachelor's degree
• Master's degree + 3 years experience in engineering field (preferably pharmaceutical or chemical process industry)
• 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
• Preferably German or another European language skills
• 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 reports.
• Prepare, review, and approve validation reports.
• Prepare, review, and approve audit reports.
• Prepare, review, and approve procedures and rationales.
• Prepare, review, and approve relevant documents.
• Evaluate new and existing regulations and trends.
• Prepare inspection and audit responses and reports.
• Perform gap analysis for efficiency improvements.
• Take appropriate actions based on gap analysis.
• Define GMP system requalification strategies with partners.
• Implement GMP system requalification strategies.
• Maintain the quality system.
• Complete practical requalification activities.
• Coordinate activities executed by external contractors.
• Execute routine and non-routine requalification/revalidation work orders.
• Document work orders in forms and OMX.
• Ensure documentation follows Good Documentation Practices.
• Participate in continuous improvement and technology development.
• Identify training needs.
• Develop training programs.
• Work safely and responsibly.
• Participate in calibration activities.

Berufserfahrung

Ausbildung

Sprachen

Tools & Technologien