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Manager Quality / Validation
Ref No.: 18-04278
Location: Swiftwater, Pennsylvania
While this is a Quality / Validation role, the Validation and autmated system experience is most important. I have requested availability for the manager to conduct a supplier call but please contact MSP with any questions in the meantime. Please stay toward the lower end of the rate card. Position is not approved to the maximum.
This position is responsible for providing Quality & Compliance oversight to site qualification / validation projects related to installations, changes and upgrades to automated systems. This position is responsible for ensuring the site policies and regulatory requirements are followed for computer system commissioning, qualification and validation projects on site.
The individual will participate in project teams and will review and approve computer validation related documentation for automated systems including but not limited to Validation Plans, User Requirements, Specifications, FATs, SATs, IOQs and PQs.
Excellent communication skills and teamwork are a must, as individual will be working with various departments. Good interpersonal and influencing skills are important for a candidate's success in this role.
This position has signatory responsibilities for all qualifications/validation issues associated with assigned area(s).

Individual should have a minimum of five years' experience in a GMP regulated environment working on validation of automated systems
The successful candidate will have a broad experience and knowledge in the following areas:
Knowledge of 21CFR Part 11, Annex 11 and GAMP V
Experience in commissioning and Qualification of control systems.
Experience with a variety of control systems including DCS, PLCs and SCADA.
Experience with HMI SCADA systems such as iFIX, Rockwell RSView and Wonderware.
Experience with Batch Systems such as Proficy batch execution and RSBatch.
Experience with PLCs such as Rockwell Client Fanuc, Siemens and Modicon