Validation Engineer — Pharmaceutical Manufacturing

Job overview

The Validation Engineer role is onsite in South Carolina for a project with a minimum duration of nine months. Compensation is not specified. The project addresses audit findings and gaps in the site’s validation program. The engineer executes validation work and assesses qualification documentation for equipment and aseptic processing. The role helps identify gaps, recommend mitigation strategies, and guide execution so the site’s validation effort can progress and support qualification expectations.

What you'll do

• Execute validation activities and gap assessments for equipment qualification, tank qualification, mixing studies, smoke studies, aseptic technique, and instrument/equipment qualification
• assess IOQ/OQ documentation and gaps between OQ and PQ
• support product-specific mixing studies and tank qualification
• support smoke study execution in aseptic processing
• guide internal resources and manage execution
• support protocol execution and documentation
• recommend strategies to address validation gaps.

What we're looking for

Skills & competencies

validation engineer

south carolina

onsite project

pharmaceutical manufacturing

equipment qualification

tank qualification

mixing studies

aseptic processing

smoke studies

ioq/oq/pq

gap assessments

Work arrangement

• Weekend coverage required

Why this role

The posting seeks pharmaceutical, biotech, or aseptic manufacturing validation experience, including equipment and tank qualification, IOQ/OQ/PQ, mixing studies, and smoke studies.

About the employer

Karwell Technologies is hiring for this role. Industry: Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Sector: 54.