Job Description

Role: Validation/Testing Analyst II

100% onsite

Location: North Chicago, IL 60064

Need strong background in the pharmaceutical or medical device industry



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Top 3 5 Skills Needed for each role

• 3-5 years of relevant experience supporting laboratory computerized systems, system validation, or QC laboratory operations in a regulated environment.
• Hands-on experience creating, configuring, testing, or validating custom calculations in Waters Empower and Sample Manager LIMS.
• Working Knowledge of computerized system validation, GMP, and good documentation practices.
• Effective written, verbal, and interpersonal communication skills.
• Ability to work independently and collaboratively while managing priorities and delivering results.

Position Purpose:

• The Laboratory Systems Validation Specialist is responsible for creating, configuring, testing, and validating custom calculations in Waters Empower and Sample Manager LIMS.
• This role develops, executes, and documents verification and validation activities; investigates discrepancies; and prepares and routes protocols, reports, and supporting documentation through the applicable quality system.
• The specialist collaborates with QC laboratory personnel, system owners, Quality, and cross-functional stakeholders to ensure solutions meet laboratory requirements and comply with applicable procedures and GMP documentation practices.

Key Responsibilities:

• Create, configure, test, and validate custom calculations in Waters Empower to support laboratory testing and data evaluation.
• Create, configure, test, and validate custom calculations in SampleManager LIMS.
• Develop, revise and route custom calculation verification and validation protocols, reports and supporting documentation through the applicable quality system, such as OneTrack, for review and approval.
• Execute verification and validation activities and document results in accordance with applicable procedures and GMP documentation practices.
• Investigate and document discrepancies or unexpected results identified during verification and validation testing.
• Collaborate with QC laboratory personnel, system owners, Quality, and other cross-functional stakeholders to understand requirements and ensure solutions meet laboratory needs.
• Manage assigned activities and priorities to support timely completion of validation deliverables.
• Perform other responsibilities as assigned.

Qualifications:

List required and preferred qualifications (up to 10). Include education, skills and experience.

• Bachelor's degree or equivalent experience in Information Technology, Computer Science, Chemistry, Biology, or a related field.
• 3-5 years of relevant experience supporting laboratory computerized systems, system validation, or QC laboratory operations in a regulated environment.
• Hands-on experience creating, configuring, testing, or validating custom calculations in Waters Empower and Sample Manager LIMS.
• Working Knowledge of computerized system validation, GMP, and good documentation practices.
• Effective written, verbal, and interpersonal communication skills.
• Ability to work independently and collaboratively while managing priorities and delivering results.

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