Validation Engineer

About the Role

This position supports system owners with the generation and management of IT-related documents for instrument qualification and computerized system validation, ensuring compliance with associated regulations. Activities focus on IT functions related to laboratory analytical instruments used in engineering, chemistry, and information technology areas for Baxter R&D, all performed in compliance with internal Baxter Quality System procedures.

Responsibilities

• Support IT-related activities for laboratory systems, including Atomic Absorption, Gas Chromatographs, Liquid Chromatographs, Mass Specs, Electron Microscopes, NMRs, Engineering, and Infuscale systems.
• Apply knowledge of cGXPs, relevant SOP curriculum, routine project procedures, project management, and other training as appropriate.
• Serve as IT project lead for projects of intermediate scope and cross-functional teams.
• Set up, install, and upgrade new PCs for lab equipment as needed.
• Support IT functions for the qualification of new equipment, coordinate system change control requests, re-qualification activities, and manage system retirements and periodic reviews.
• Support all labs in Round Lake, including Tech1, Tech2, DDEL, WG, and the Penicillin building, containing validated systems.
• Support Active Directory and Data Integrity projects.
• Perform System Administrator duties for Agilent OpenLab ECM and Xybion Compliance Builder.
• Monitor the Service Now Help Desk ticketing system for application-related issues.
• Perform IT-related technical reviews of validation package deliverables.
• Support all Windows Operating Systems, including XP, Windows 7, 8, and 10, as well as Macintosh and PC-based systems.
• Manage and archive all software and/or hardware for approved package documents.
• Handle routine tasks accurately and in a timely manner.

Requirements

• 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.
• Proficiency in computer software and hardware, Microsoft Word, and Excel.
• Minimum BS degree in a technical area or 6 years of related experience within a pharmaceutical, biotechnology, or related industry.

Skills

• Excellent organizational, oral, and written communication skills.

Pay

Pay Range Minimum: $95,000 per year
Pay Range Maximum: $151,000 per year

Benefits

• Medical, dental, vision, pharmacy, life, accidental death & dismemberment, and disability insurance.
• Employee assistance program.
• 401(k) retirement plan.
• 10 days of paid time off per year (some positions eligible for need-based leave with no designated number of leave days).
• 10 paid holidays per year.
• Eligibility for performance-based bonuses subject to company policies.