Candidates must have excellent verbal communication and technical writing skills.
Proficient in Microsoft Word, Excel, Power Point and Project.
Experience with all pertinent industry best practices (e.g., ISPE GAMP) including development and execution of all applicable system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report).
Working knowledge of the development of protocols for the Validation of complex computer systems (e.g., multiple GAMP classes of systems); Protocol development will include ability to develop Installation, Operational and Performance qualification documents.
Experience in development of Validation Master Plans for simple systems or facilities.
Experience in Project execution within at least one area of systems validation - e.g., laboratory equipment, facilities utilities, manufacturing equipment, metrology equipment, information systems.
Ability to take and perform complex validation assignments, quality assurance assignments (where applicable) and other related job assignments as may be necessary for execution of the specific job activities.
Understanding of computer networking essentials and troubleshooting skills including but not limited to Windows OS, Server OS, SQL Server, Ethernet, TCP/IP, ODBC, SMTP, DHCP, routing, and switching.
Effective written and oral communication skills; ability to write, type, express or exchange ideas; ability to convey information/instructions accurately.
Carry out duties and responsibilities with limited supervision.
Flexibility to work occasional weekends and evenings.
Ability to walk, stand and move about for long periods of time; work with equipment in the field including basic hand tools, lift and manipulate reasonable weights (approximately 35 lbs.), ability to sit and type for long periods of time.
Ability to plan and manage own work.
Qualifications:
Qualified candidates will possess:
Bachelor's degree in scientific or engineering discipline along with 5 plus years of experience in the field of computer validation.
Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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