GxP Validation Analyst

GxP Validation Analyst

Lead I - Software Testing

Who We Are:

Born digital, UST transforms lives through the power of technology. We walk alongside our clients and partners, embedding innovation and agility into everything they do. We help them create transformative experiences and human-centered solutions for a better world.

UST is a mission-driven group of 29,000 practical problem solvers and creative thinkers in more than 30 countries. Our entrepreneurial teams are empowered to innovate, act nimbly, and create a lasting and sustainable impact for our clients, their customers, and the communities in which we live.

With us, you'll create a boundless impact that transforms your career-and the lives of people across the world.

Visit us at UST.com.

You Are:

We are seeking an experienced GxP Validation Analyst to support a global instrument software validation initiative involving 200 unique laboratory instruments. This role focuses on documenting and validating software installed on lab instrumentation in compliance with EMA guidelines (Annex 11) and migrating instrument software management to IT SOPs. The analyst will collaborate with cross-functional teams to ensure regulatory compliance and seamless integration of software management practices.

The Opportunity:

* Gather and document user requirements (URS) and software configurations.

* Develop and execute validation protocols (IQ, OQ, PQ as applicable).

* Prepare requirement specifications, infrastructure diagrams, and data flow documentation.

* Perform risk assessments and maintain traceability from requirements risks tests results.

* Support migration and alignment of instrument software management with IT SOPs.

* Ensure compliance with EMA guidelines and GAMP principles.

* Communicate effectively with laboratory, IT, QA, and vendor teams throughout the project lifecycle.

This position description identifies the responsibilities and tasks typically associated with the performance of the position. Other relevant essential functions may be required.

What You Need:

* Bachelor's degree in Life Sciences, Computer Science, or Engineering.

* 6-9 years of relevant validation experience (pharma, biotech, or CRO preferred).

* Familiarity with CSA (Computer Software Assurance) principles is a plus.

* Strong technical writing and documentation skills.

* Proven experience in software validation for lab instruments or GxP systems.

* In-depth knowledge of EMA guidelines, Annex 11, and GAMP 4.

* Ability to create infrastructure and data flow diagrams.

* Detail-oriented with excellent communication and stakeholder engagement skills.

Compensation can differ depending on factors including but not limited to the specific office location, role, skill set, education, and level of experience. UST provides a reasonable range of compensation for roles that may be hired in various U.S. markets as set forth below.

Role Location: Kentucky

Compensation Range: $68,000-$102,000

Benefits

Full-time, regular employees accrue a minimum of 10 days of paid vacation per year, receive 6 days of paid sick leave each year (pro-rated for new hires throughout the year), 10 paid holidays, and are eligible for paid bereavement leave and jury duty. They are eligible to participate in the Company's 401(k) Retirement Plan with employer matching. They and their dependents residing in the US are eligible for medical, dental, and vision insurance, as well as the following Company-paid Employee Only benefits: basic life insurance, accidental death and disability insurance, and short- and long-term disability benefits. Regular employees may purchase additional voluntary short-term disability benefits, and participate in a Health Savings Account (HSA) as well as a Flexible Spending Account (FSA) for healthcare, dependent child care, and/or commuting expenses as allowable under IRS guidelines. Benefits offerings vary in Puerto Rico.

Part-time employees receive 6 days of paid sick leave each year (pro-rated for new hires throughout the year) and are eligible to participate in the Company's 401(k) Retirement Plan with employer matching.

Full-time temporary employees receive 6 days of paid sick leave each year (pro-rated for new hires throughout the year) and are eligible to participate in the Company's 401(k) program with employer matching. They and their dependents residing in the US are eligible for medical, dental, and vision insurance.

Part-time temporary employees receive 6 days of paid sick leave each year (pro-rated for new hires throughout the year).

All US employees who work in a state or locality with more generous paid sick leave benefits than specified here will receive the benefit of those sick leave laws.

What we believe:

We proudly embrace the values that have shaped UST since day one. We build our culture of Humility, Humanity, and Integrity. These values inspire us to nurture a people-first, human centric culture that fosters diversity, prioritizes sustainable solutions, and keeps our people and clients at the forefront of all decisions.

Humility:

We will listen, learn, be empathetic and help selflessly in our interactions with everyone.

Humanity:

Through business, we will better the lives of those less fortunate than ourselves.

Integrity:

We honor our commitments and act with responsibility in all our relationships.

Equal Employment Opportunity Statement

UST is an Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other applicable characteristics protected by law. We will consider qualified applicants with arrest or conviction records in accordance with state and local laws and "fair chance" ordinances.

UST reserves the right to periodically redefine your roles and responsibilities based on the requirements of the organization and/or your performance.

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