**W2 Only
Job Title: Sr. Computer system Validation Engineer
Location: St. Joseph, MO
Duration: 01/27/2025 – 01/30/2026
Job Type: Contract
Job Description:
We are seeking an experienced Senior Computer System Validation Engineer to support critical validation activities for regulated laboratory systems and equipment. The ideal candidate will be responsible for authoring validation documentation, conducting testing, and ensuring compliance with regulatory standards.
Key Responsibilities:
- Author validation documents including validation plans, user requirement specifications (URS), risk assessments, IQ/OQ/PQ protocols, trace matrices, and summary reports.
- Validate GMP laboratory systems and equipment, ensuring compliance with applicable regulations and standards (e.g., 21 CFR Part 11, Annex 11).
- Perform system testing and ensure applications meet defined requirements per validation plans.
- Identify and escalate project risks and issues to the CSVC Manager.
- Collaborate with cross-functional teams to define test cases and ensure alignment with business processes.
- Prepare detailed reports on defects and issues identified during system testing.
- Act as a subject matter expert for critical GxP end-use applications.
Required Skills and Experience:
- Minimum 5 years of experience in computer system validation within GMP-regulated environments.
- Proficiency in technical writing and documentation for validation processes.
- Strong understanding of GxP regulations and standards (e.g., 21 CFR Part 11, Annex 11).
- Demonstrated expertise in system testing and validation for healthcare or related industries.
- Excellent analytical, problem-solving, and organizational skills.
- Effective communication skills, both written and verbal.
- Self-motivated and able to work independently while managing multiple priorities.
Educational Requirements:
- Bachelor’s degree in Science, Technical Writing, or a related field.
Schedule:
- Full-time, 40 hours per week.
This position offers a unique opportunity to contribute to validation projects in a regulated environment, ensuring quality and compliance in laboratory operations.