Computerized Systems Validation Engineer

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 a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps their customers deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, Bioscience, Biopharmaceuticals, Custom manufacturing, Biotechnology, Life science ingredients, Nutrition, Microbial Control, Agriculture, Materials Science, Personal Care, and cell and gene therapy.

Job Title: Computerized Systems Validation Engineer

Duration: 6 Months

Job Type: Temporary Assignment

Work Type: Onsite

Pay Range: $30 to $45 - Depends on experience and flexible

Please Note: Applicants must be currently authorized to work full-time in the United States for any employer. This role does not offer visa sponsorship, now or in the future, and only W2 candidates will be considered for this position.

Summary

Support qualification and validation activities within the CQV department. This role will provide validation support for analytical laboratory instruments, computerized systems, and GMP equipment while partnering closely with the Instrumentation and CQV teams. The successful candidate will split time supporting CQV priorities and Instrumentation team CSV activities, manage multiple priorities simultaneously, produce high-quality documentation, and work hands-on with laboratory instruments and equipment in a regulated cGMP environment. Onsite presence is required.

Responsibilities

• Develop, execute, review, and maintain validation lifecycle documentation, including Risk Assessments, User Requirement Specifications (URS), Design Specifications, Traceability Matrices, Test Scripts, Validation Protocols, Discrepancies and Deviations, Summary Reports, Periodic Review Documentation, and System Retirement Documentation.
• Support qualification and validation activities for new and existing analytical laboratory instruments, computerized systems, and GMP equipment.
• Execute and support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.
• Ensure calibration readiness, data integrity verification, and compliance with 21 CFR Part 11 and Annex 11 requirements.
• Partner with Quality Control, Instrumentation, Engineering, Automation, Quality Assurance, and system owners to plan and execute validation activities.
• Prepare and support change controls, impact assessments, deviations, CAPAs, and validation protocols related to GMP equipment, analytical instruments, and computerized systems.
• Utilize and support the Kneat validation platform, including document creation, workflow routing, approvals, and record closure.
• Assist with Kneat template development and continuous improvement initiatives.
• Maintain inspection-ready documentation in accordance with SOPs, GxP requirements, and site procedures.
• Monitor field execution activities, identify gaps early, drive discrepancy resolution, and elevate issues as appropriate.
• Split support between the Instrumentation team for CSV activities and the CQV group for qualification execution, documentation updates, and readiness activities.
• Travel between campus buildings as needed to support laboratory instrument and equipment qualification activities.
• Perform other duties as assigned.

Required Skills

• Bachelor's Degree in Engineering, Life Sciences, Chemistry, Biology, or a related scientific discipline preferred.
• Minimum 3-5 years of CQV and/or CSV experience within pharmaceutical, biotechnology, or other regulated industries.
• Experience supporting analytical laboratory instruments and equipment qualification.
• Experience working in cGMP-regulated environments.
• Experience with computerized systems validation and equipment qualification.
• Experience managing multiple validation projects and competing priorities.
• Previous backlog remediation or high-volume validation support experience is highly desirable.
• Strong understanding of GMP documentation requirements and validation practices.
• Knowledge of GxP regulations, 21 CFR Part 11, 21 CFR Parts 210 and 211, EU Annex 11, Annex 15, USP and ASTM standards.
• Understanding of computerized systems, laboratory instruments, pharmaceutical manufacturing equipment, specifications, procedures, and engineering drawings.
• Strong understanding of equipment qualification versus instrument validation requirements.
• Excellent technical writing and documentation skills.
• Strong organization and attention to detail.
• Ability to prioritize effectively across multiple projects and stakeholders.
• Proactive problem-solving skills.
• Ability to work both independently and collaboratively in a regulated environment.
• Strong communication and cross-functional collaboration skills.
• Commitment to quality, compliance, and data integrity.
• Work within a clean, secure, and regulated GMP environment.
• Wear required PPE, including lab coats, safety glasses, gloves, and other protective equipment as required.
• Occasional lifting of up to 50 pounds.
• Travel between site buildings as needed.
• Flexible schedule to support project activities.

TekWissen® Group is an equal opportunity/affirmative action Employer (m/f/d/v) supporting workforce diversity.