Senior CSV Engineer
Our client is a leading and rapidly expanding Biologics company looking for a Senior CSV engineer with CSV Strategy and Execution experience, to support them meet their customers’ needs and drive manufacturing process and teams.
Primary resource for the development, execution, review, and approval of Computerized Systems Validations and generation of applicable documentation in support of the Computerized System Life Cycle in accordance with 21 CFR Part 11 and GAMP5. Provides guidance for equipment/software related issues and consults with Equipment Owners, IT and QA Management to resolve complex quality issues in a timely manner.
This role will be hands-on and highly cross-functional working closely with various departments who work with GXP systems
- Works cross functionally with System Owners, IT, and QA Representative for Equipment/Software Validations and provide expertise on equipment/software validations.
- Collaborate with testing and manufacturing personnel, system vendors, IT, and QA to support new systems introduction for GXP use (including support with developing URS and FDS).
- Write, execute, review, or approve Equipment and Software Validations (IQ, OQ, PQ); work with IT and applicable system vendors in creating test scripts as required.
- Write, execute, review, or approve Change Controls. assess impact to qualified state of systems for proposed changes; develop appropriate mitigation plan, as applicable.
- Stay current with changes to GXP, including FDA and EU and other regulatory bodies as well as guidance documents (i.e.: ICH, ISPE, GAMP, ISO, etc.).
- Participate in quality and process improvement initiatives, and project teams.
- Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required.
- 8 or more years of relevant experience or equivalent
- Bachelors’ degree in a Science related field or equivalent experience
- The ideal candidate will be dynamic with an eye for detail
- Previous experience working on start-up projects is ideal but not essential
- Knowledge of 21 CFR Part 11 and ISPE GAMP5 is required.
- Knowledge of GLP and cGMP requirements, PTC guidelines and ISO17205 is highly desirable.
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
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