Principal Manufacturing Compliance Engineer

Join us as a Principal Manufacturing Compliance Engineer, where you will lead technical and compliance initiatives within Genentech Oceanside. Oversee complex regulatory issues, drive operational excellence, and ensure adherence to cGMP standards. Ideal for experienced professionals in biopharmaceutical compliance with strong technical expertise and leadership skills.

Skills

• cgmp compliance
• root cause analysis
• deviation management systems
• capa execution
• process validation
• change control
• biopharmaceutical product purification
• fda regulations
• ich guidelines
• european regulatory guidelines
• technical writing
• standard operating procedures
• cross-functional collaboration
• quality systems
• environmental monitoring
• performance metrics analysis
• mentoring
• risk mitigation
• microbial contamination risk management
• corrective and preventative action
• manufacturing operations
• process improvement