Validation Scientist-Pharma

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.

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

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).

Pay

Competitive Salary, Great Benefits, and Relocation Assistance Provided.

Benefits

• 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

Schedule

Day Shift