
Validation Analyst - GMP Lab / LIMS
Provides basic business/system support of software systems and/or laboratory instrumentation. Works with staff of various departments and the client to initiate and complete performance qualification (PQ) validation. Facilitates the validation process and implementation of system upgrades, including guiding, testing, supporting the introduction and ongoing support of software systems. Works with business analysts to understand application requirements. Develops and executes test protocols. Documents test results. Ensures application changes are appropriately tested and documented. Reviews and approves all change controls associated with validated systems per SOP. Reviews PQ and change control documentation with leadership per SOP.
Client-focused approach with strong interpersonal skills, and strong oral and written communication skills and ability to teach others
Prior LIMS validation experience in a pharmaceutical or medical device setting
Ability to review and critique SDLC documentation including requirements, functional design, system design, and test plans.
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
MS Project
Time Management Skills
MS Excel skills
Strong troubleshooting skills
PowerPoint skills
21 CFR Part 11 and/or Annex 11
Client-focused approach
Verbal communication
written communication
Attention to detail
Problem-solving and resourcefulness
Results-Driven
Multi tasker
Flexible Approach
According to JobzMall, the average salary range for a Validation Analyst - GMP Lab / LIMS in 8551 Research Way, Middleton, WI 53562, USA is $62,000 to $92,000. This range is based on salaries reported by job seekers and employers in the area.
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Thermo Fisher Scientific is a U.S.-based provisioner of scientific instrumentation, reagents and consumables, and software and services to healthcare, life science, and other laboratories in academia, government, and industry.

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