Job Opportunity: Qualification Specialist – Equipment Integration (Contract)
We are seeking an experienced Qualification Specialist to join our Equipment Integration team, playing a critical role in transferring existing Lab Equipment from our Spark Network to the Roche Connect Network (RCN).
If you are a seasoned Validation professional ready to lead compliance for digital solutions and infrastructure in a fast-paced GMP environment, this is for you!
Key Requirements & Experience Needed (Must-Haves):
- 9+ years in Computer Systems Validation (CSV) or Equipment Qualification within the Pharmaceutical/Life Sciences industry (GMP/GxP).
- Proven experience in developing a Validation Master Plan (VMP) from scratch.
- Strong practical experience with the PI Historian System.
- Expertise in qualifying integrated hardware, software, and automation applications (IQ/OQ/PQ) against GAMP 5 and 21 CFR Part 11.
- Background in managing infrastructure through multiple product releases and overseeing end-to-end data migration/configuration.
