Job Description
Are you ready to lead computer system validation that safeguards data integrity and accelerates reliable manufacturing for people living with rare diseases? As CSV Lead Engineer, you will shape the digital backbone of GMP operations, driving compliant performance across MES, DeltaV and other critical systems that keep vital therapies moving.
In this role, you will turn regulations into practical testing strategies and risk-based validation, guiding teams across Bulk Drug Substance, Packaging and Laboratory areas. Your decisions will simplify qualification, strengthen data integrity, and reduce time to implement new equipment and systems. Do you see opportunities to streamline while raising the bar on compliance and quality?
Accountabilities:
- Validation Leadership: Serve as the subject matter expert for GMP computer systems, including MES and DeltaV, setting direction, standards and best practices.
- Regulatory Alignment: Ensure validation strategies alig...
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