American Regent, Inc. (Shirley, NY) seeks Senior GxP Systems Specialist to gather infrastructure and architectural requirements pertaining to relevant projects and support, coordinate, and interface with regulatory agencies. Min. req.: Bach. deg. or for. equiv. in Chemistry, Biology, Information Systems, Pharmacy Management Systems or a related field plus five (5) years experience as GxP computer systems analyst, validation engineer or related experience in pharmaceutical or similarly regulated industry and five (5) years of exp. with: computerized systems regulations, including CFR Part 11; Quality Systems and current Good Manufacturing Practice (cGMP) requirements (FDA, EU, ICH) and assessing compliance risks; Providing oversight in implementation and maintenance of GxP computer systems in a validated state; Validation methodology and software development life cycle (SDLC) principles. Upon hiring, successful applicants must provide evidence of 20/20 vision (corrective lenses allowed); and must successfully pass Color Blindness Screening (D15); successful applicants must be physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. Salary: $121,659. Apply online at: https://americanregent.com/Careers or send resume to: Attn: John Rossini, Talent Acquisition Director, JRossini@americanregent.com, or 5 Ramsey Road, Shirley, NY 11967. Please reference Req. ID R-102234. No calls. EEO/AA employer.

Minimum Salary: 121659.00 Maximum Salary: 121659.00 Salary Unit: Yearly