Validation Engineer

Summary:
This position will have primary responsibility for supporting system owners with the generation and management of IT related documents for instrument qualification and computerized system validation process to ensure compliance with the associated regulations. These activities will focus on IT related functions involved with laboratory Analytical Instruments utilized in the engineering, chemistry, and information technology areas for R&D. All activities must be performed in compliance with internal Quality System procedures.

Essential Duties and Responsibilities:
This position is responsible for supporting IT related functions as applicable to Analytical Instruments per Quality System procedures.
Under moderate oversight by senior team member or manager, the incumbent will:
· Support IT related activities for all laboratory systems including Atomic Absorption, Gas Chromatographs, Liquid Chromatographs, Mass Specs, Electron Microscopes, NMR's, Engineering and Infuscale systems.
· Apply knowledge or quickly learn cGXPs, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate.
· Serve as IT project lead with projects of intermediate scope and cross-functional teams.
· Set up and install/upgrade new PC's when needed for lab equipment
· Support IT functions for the qualification of new equipment,
coordinate system change control requests and re-qualification activities, as well as manage systems retirements and periodic reviews.
· Support all labs in Round Lake including Techl, Tech2, DDEL, WG, and the Penicillin building that contain Validated Systems.
· Support Active Directory and Data Integrity project.
· Perform System Administrator duties for Agilent OpenLab ECM and Xybion Compliance Builder.
· Monitor the Service Now Help Desk ticketing system for any App related issues.
· Perfoms IT related technical reviews of validation package deliverables.
· Support all Windows Operating Systems, including XP, Windows 7, 8, and 10.
· Support Macintosh as well as PC based systems.
· Management and archival of all software and/or hardware for approved package documents.
· Handle routine tasks timely, accurately.
Qualifications: ·
Solid understanding of IT functions related to the instrument qualification process.
· Direct or indirect industry knowledge.
· Ability to communicate effectively at all levels in verbal and written form, including technical/business writing.
· Excellent organizational skills.
Ability to work independently or in teams, Proficient in Computer
Software and hardware, Microsoft Word and Excel Must have excellent organizational, oral and written communication skills.
Education and/or Experience:
Include the education and experience that is necessary to perform the job satisfactorily.
Minimum BS degree in technical area or 4 years related experience within a pharmaceutical, biotechnology or related industry