Beschreibung

In this role, you will lead global cleanroom operations, ensuring compliance and contamination control. Your day-to-day responsibilities will involve guiding teams, developing training programs, and implementing standards to foster a culture of continuous improvement.

Anforderungen

• •Bachelor’s or Master’s degree in pharmaceutical or biotechnology engineering, microbiology, or related field
• •At least 5 years of experience in cleanroom setup, management or operation and/or environmental monitoring/microbiology in the pharmaceutical industry
• •Knowledge of relevant ISO and GMP standards for cleanrooms
• •Experience working in a regulated environment, including design and implementation of GMP-compliant processes and procedures
• •Good communication skills
• •Fluency in English; German would be beneficial
• •Project management skills and/or work experience in cross-functional teams would be an add-on

Aufgaben

• •Act as Global Process Owner for cleanroom quality processes
• •Provide guidance for contamination control strategy implementation
• •Lead cross-functional teams to define cleanroom standards
• •Develop and deliver training on cleanroom practices
• •Support the rollout of cleanroom standards
• •Provide methods for gap assessments of processes
• •Define and enforce gowning requirements for environments
• •Develop global monitoring programs for cleanroom data
• •Support qualification and validation of cleanroom facilities
• •Assist in root cause analysis for issues and deviations
• •Track and assess new regulatory requirements and trends

Benefits