CQV Engineer — Life Sciences Validation Expert

Clark & Enersen; Indianapolis (IN); On-site; USD 80,000 - 95,000; Full time

Benefits offered by this job

Competitive compensation

Career development

Work-life balance

Job summary

Eliquent Life Sciences is seeking a Validation Engineer to join the Indianapolis team. The role involves developing and maintaining validation documentation for new cleanrooms and packaging equipment, ensuring compliance with site, corporate, and regulatory standards.

Responsibilities include executing FAT/SAT/IQ/OQ/PQ protocols, assisting with risk assessments and data integrity reviews, and supporting deviations investigations under supervision.

Qualifications

• Bachelor's degree in engineering, science, or equivalent experience.
• 2–5 years of validation experience in regulated manufacturing (biotech/pharma/medical devices).
• Experience executing validation protocols including systems, utilities, equipment qualification.
• Familiarity with FDA/cGMP regulations and documentation practices.

Responsibilities

• Write procedures, investigations, protocols, reports and change controls to support multiple departments.
• Generate validation lifecycle documents (FAT, SAT, IQ/OQ/PQ) for cleaning, sterilization, and facilities.

Skills

Validation experience

Documentation

Regulatory knowledge

Education

Bachelor's degree in engineering or science

Job description

Eliquent Life Sciences is seeking a Validation Engineer to join the Indianapolis team. The role involves developing and maintaining validation documentation for new cleanrooms and packaging equipment, ensuring compliance with site, corporate, and regulatory standards.

Responsibilities include executing FAT/SAT/IQ/OQ/PQ protocols, assisting with risk assessments and data integrity reviews, and supporting deviations investigations under supervision.