Sr. Validation Engineer(m/w/x)

Description

In this role, you will ensure excellence by managing GMP requalification strategies and regulatory compliance while coordinating with external partners to maintain a safe, high-quality production environment.

Requirements

• •Degree in Biotechnology, Engineering, or related field
• •10 years experience or Master's degree with 3 years experience
• •Knowledge of cGMPs and manufacturing operations
• •Pharmaceutical industry experience in qualification and validation
• •Experience in multi-cultural work environments
• •Excellent communication in English and German
• •Understanding of GMP standards and regulations
• •Excellent technical writing and attention to detail
• •Proficiency in MS Office and PC applications
• •Strong communication and interpersonal skills
• •Certification in technical writing or quality management
• •Experience with Documentum, TrackWise, or EDMS

Tasks

• •Prepare and approve production and validation documents
• •Review audit reports, procedures, and rationales
• •Evaluate new regulations and regulatory trends
• •Prepare responses for inspections and customer audits
• •Perform gap analyses to resolve efficiencies
• •Define and implement GMP system requalification strategies
• •Maintain the quality system and complete practical activities
• •Coordinate activities performed by external contractors
• •Execute and document requalification work orders
• •Follow Good Documentation Practices for all operations
• •Contribute to continuous improvement and technology development
• •Identify and develop necessary training programs
• •Maintain a safe and incident-free workplace
• •Participate in routine calibration activities

Tools & Technologies