Position Purpose:
The Laboratory Systems Validation Specialist is responsible for creating, configuring, testing, and validating custom calculations in Waters Empower and SampleManager 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 SampleManager 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.
EEO:
“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”