Validation Scientist-Pharma

Validation Scientist – Pharmaceutical

Location: San Antonio, TX

Employment Type: Direct Hire

Work Schedule : Day Shift

Compensation & Perks: Competitive Salary, Great Benefits, and Relocation Assistance Provided

About the Role

We are seeking a dedicated and experienced Validation Scientist to join our Technical Services team at our pharmaceutical manufacturing facility in San Antonio, TX. In this role, you will play a critical part in supporting manufacturing operations by overseeing change controls, validations, equipment qualifications, and investigations into non-conformances, deviations, and out-of-specification results.

This is a Direct Hire opportunity offering comprehensive benefits, professional growth, and relocation assistance for qualified candidates willing to relocate to San Antonio.

Key Responsibilities

• Prepare Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), and Re-Qualifications for new or modified manufacturing and laboratory equipment and systems.

• Prepare, review, and execute process validation, bulk hold, and packaging validation studies. Analyze validation test data to determine successful compliance with established criteria.

• Prepare, review, and execute cleaning validation studies, coordinate sampling schedules, determine cleaning limits, and evaluate cleaning procedures for new raw materials and products in partnership with Production and Laboratory teams.

• Prepare, review, and execute spreadsheet validations, develop/modify QC laboratory spreadsheets, and conduct qualification tests on computer-controlled processes, equipment, and software.

• Gather technical cross-functional information (Production, Maintenance, QA/QC) to prepare Facility/Equipment Change Control Documents and assess impact.

• Perform routine testing and report preparation for compressed air systems, particulate air monitoring, building/stability chamber mapping studies, and annual purified water system reviews.

• Review Out of Specification (OOS) and Out of Trend (OOT) results. Perform thorough investigations by conducting risk assessments, determining containment actions, identifying root causes, and formulating Corrective and Preventive Actions (CAPA).

• Draft detailed summary reports, audit qualification processes to ensure strict compliance with internal policies and regulatory standards and maintain tracking databases.

Qualifications, Education & Experience

• Bachelor’s degree from a four-year college or university, preferably in Engineering, Chemistry, or an Applied Science. (Note: Relevant industry work experience may be considered in lieu of a college degree).

• Minimum of 3 years of experience working within the pharmaceutical, biopharmaceutical, or regulated manufacturing industry.

• Proven knowledge and technical competence across multiple Technical Services categories (such as equipment qualification, process validation, cleaning validation, computer system validation, or quality investigations).

What We Offer

• Direct Hire Career Opportunity

• Comprehensive Benefits Package (Medical, Dental, Vision, 401(k) matching, and more)

• Relocation Assistance for candidates moving to the San Antonio area

• Professional development and collaborative team environment

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As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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About Kelly

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