CSV Engineer

Responsibilities:

Author Qualification (IQ/OQ) Final Reports for Application upgrade projects.

Author and review validation protocols including IQ, OQ, and PQ protocols related to Computer Systems for Manufacturing equipment such as bioreactors, TFFs, tube welders, AKTAs, glove integrity testers, filter integrity testers, controlled temperature units etc.

Author and Review of Validation Deliverables

Validation Master Plan (VMP), System Impact Assessment, Risk Assessment, User Requirement Specification Document, Design Specification Document, Configuration Specification document, Data Integrity Assessment, Application Qualification Protocol (IQ/OQ/PQ), Validation Summary Reports.

Ensure site systems are compliant with the corporate Data Integrity program.

Requirements:

Available to work onsite in Baltimore MD

Experience in GMP regulated environment

Proven attention to detail and organization in project work

Capable of working on assigned tasks without mentorship

Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate

Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the client's organization

Ability to communicate effectively with clients

Proven ability to identify areas of business expansion and report to management team for follow-up.

#J-18808-Ljbffr