Senior Validation Scientist

Mission Pharmacal Company; Boerne (TX); Hybrid; USD 75,000 - 110,000; Full time

Job summary

Mission Pharmacal Company is seeking a validation professional to support equipment qualifications, process and cleaning validations, and computer system validation. The role involves preparing IQ/OQ/PQ protocols, coordinating change control, and performing comprehensive testing across utilities and environmental systems.

The position requires a Bachelor’s degree in engineering, chemistry, or applied science with about three years of pharmaceutical/manufacturing experience.

Qualifications

• Bachelor’s degree from a four-year college or university; preferably in engineering, chemistry, or applied science and three years’ experience in the pharmaceutical, biopharmaceutical, or manufacturing industry.

Responsibilities

• Support validation department goals by performing equipment qualifications, process validations, cleaning validations, and CSV validations.
• Prepare IQ, OQ, PQ, and re-qualification documents for equipment and systems.
• Coordinate change control documents by gathering information from Production, Maintenance, and QA/QC.
• Perform routine testing and reporting for compressed air, air monitoring, and environmental mappings.
• Audit qualification processes for compliance with internal policies and regulatory requirements.
• Prepare, review, and execute process validation studies and analyze results against criteria.
• Assist with preparing IQ/OQ/PQ protocols and generate change-control documents from production and QA data.
• Prepare detailed reports and coordinate sampling/testing with affected departments, ensuring schedule adherence.
• Prepare, review, and execute CSV tests; develop SOPs and test cases for software in QC labs.

Skills

Validation expertise

Quality Assurance

Documentation

Cross-functional collaboration

Education

Bachelor’s degree

Tools

IQ/OQ/PQ protocols

Job description

Mission Pharmacal Company is seeking a validation professional to support equipment qualifications, process and cleaning validations, and computer system validation. The role involves preparing IQ/OQ/PQ protocols, coordinating change control, and performing comprehensive testing across utilities and environmental systems.

The position requires a Bachelor’s degree in engineering, chemistry, or applied science with about three years of pharmaceutical/manufacturing experience.