Onsite CSV Engineer - IQ/OQ/PQ & Regulated Lab Systems

TekWissen ®; Bend (OR); On-site; USD 41,000 - 62,000; Part time

Job summary

TekWissen is seeking a Computerized Systems Validation Engineer for a 6-month on-site engagement with a leading biopharma client in the United States. The role focuses on qualification and validation of analytical instruments, computerized systems, and GMP equipment within a cGMP environment.

The role manages IQ/OQ/PQ, maintains validation docs, ensures data integrity and 21 CFR Part 11, and collaborates with CQV, Instrumentation, Engineering, and QA teams.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Chemistry, Biology, or related field.
• 3–5 years CQV/CSV experience in pharma/biotech or regulated industries.
• Experience with analytical laboratory instruments and equipment qualification.
• Familiarity with cGMP documentation and GMP practices.
• Knowledge of 21 CFR Part 11, EU Annex 11, USP/ASTM standards.

Responsibilities

• Develop, execute, review, and maintain validation lifecycle documentation including URS, Design Specs, and Validation Protocols.
• Support IQ/OQ/PQ for instruments and GMP equipment.
• Ensure data integrity and compliance with 21 CFR Part 11 and Annex 11.
• Collaborate with QC, Instrumentation, Engineering, QA, and system owners.
• Travel between campus buildings to support qualification activities.

Skills

CQV/CSV experience

Documentation skills

Regulatory compliance

Cross-functional teamwork

Problem solving

Education

Bachelor’s in Engineering/Life Sciences

Tools

Kneat Validation

Job description

TekWissen is seeking a Computerized Systems Validation Engineer for a 6-month on-site engagement with a leading biopharma client in the United States. The role focuses on qualification and validation of analytical instruments, computerized systems, and GMP equipment within a cGMP environment.

The role manages IQ/OQ/PQ, maintains validation docs, ensures data integrity and 21 CFR Part 11, and collaborates with CQV, Instrumentation, Engineering, and QA teams.