Computer System Validation Engineer

Job overview

The Computer System Validation Engineer role is listed in Raleigh, NC, and supports a global pharmaceutical client. Compensation is not specified. The role leads and executes validation activities for GxP electronic systems and applications, particularly Manufacturing Execution Systems.

What you'll do

• Author, review, or approve validation documentation
• assist business and technical owners with test execution, failure documentation, and requirements
• support Manufacturing Execution System validation
• develop and maintain validation plans, requirements, specifications, assessments, test scripts, summary reports, trace matrices, and SOPs
• support compliance with cGMP, GxP, GAMP, SDLC, 21 CFR Part 11, and good documentation practices
• support validation of pharmaceutical manufacturing and laboratory systems
• use IT service management platforms for incident, problem, and change management.

What we're looking for

Skills & competencies

computer system validation engineer

raleigh nc

katalyst healthcares & life sciences

csv

gxp

mes validation

pharmaceutical systems

cgmp

gamp

21 cfr part 11

validation documentation

Work arrangement

• Weekend coverage required

Why this role

Requires a bachelor’s degree in life sciences, engineering, IT, or a related discipline, or equivalent industry experience, and at least four years of direct computer system validation experience. GAMP, MES validation, and CSV documentation experience are specified.

About the employer

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