Validation Engineer

TechDigital Group; Deerfield (IL); On-site; USD 75,000 - 110,000; Full time

Job summary

TechDigital Group in Deerfield, IL is seeking an IT support professional to manage IT functions for instrument qualification and computerized system validation in R&D environments. You will ensure compliance with Quality System procedures and support a range of analytical instruments and IT platforms.

The role requires familiarity with cGxP, SOPs, project procedures, and cross-functional collaboration. Strong communication, organization, and problem-solving skills are essential for success in a

Qualifications

• Solid understanding of IT functions related to instrument qualification processes.
• 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.

Responsibilities

• Support IT-related activities for laboratory systems including analytical instruments.
• Learn cGxP and SOP curricula, routine project procedures, and project management principles.
• Serve as IT project lead on intermediate-scale, cross-functional projects.
• Set up and upgrade PCs for lab equipment as needed.
• Coordinate system change control requests and re-qualification activities; manage retirements and reviews.
• Support all labs in Round Lake and related facilities containing validated systems.
• Support Active Directory and data integrity projects.
• Perform system administrator duties for IT software platforms.
• Monitor Help Desk tickets for IT app issues.
• Conduct IT-related reviews of validation package deliverables.
• Support Windows OS across versions and Mac systems.

Skills

IT systems

Communication

Organizational skills

Independent / team work

Windows Macintosh

Education

BS degree in technical area

Tools

Agilent OpenLab

Xybion Compliance Builder

ServiceNow

Active Directory

Job description

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