Senior Compliance/Validation Engineer position at Genentech's Oceanside, California facility, responsible for IT OT compliance and Validation, ensuring adherence to cGMP, GSP 111, and CSV 6 requirements, and contributing to Manufacturing Operations initiatives and optimization/standardization of the global IT OT landscape.
Requirements
- Minimum of 8+ years of experience in an IT and/or OT compliance/Validation role within the biotechnical or pharmaceutical industry.
- Proven experience with cGMP, GSP 111, and CSV 6 regulations.
- Knowledge and understanding of how business processes translate into ITOT system processes is a must.
- Working knowledge of ServiceNow, Veeva, and eValRoche.
- Excellent written and verbal communication.
- Good negotiation skills.
- Collaborative skills to work effectively with internal and external stakeholders.
Benefits
- Discretionary annual bonus
- 401(k) matching
- Health insurance
- Paid time off
- Relocation assistance not available
- Other benefits detailed at the link provided below