Computer System Validation Engineer
Avid Bioservices · Tustin, CA · 1 wk ago
On-siteQuality Assurance$82k–$104k/yrFull-time
Role Overview
The Computer System Validation Engineer plays a crucial role in supporting the cGMP Manufacturing Facility and its related areas. This includes validating new installations, upgrades, replacements, and modifications of manufacturing equipment, laboratory instruments, computer systems, networks, and software. The role also involves generating and executing IQ, OQ, and PQ protocols, coordinating validation activities, analyzing qualification data, and providing validation guidance.
Responsibilities
- Provide technical validation support for manufacturing equipment, laboratory instruments, computer systems, networks, and software.
- Review and help author URS and/or Requirement Specification documents.
- Generate and execute IQ, OQ, and PQ protocols, engineering studies, and final reports.
- Celebrate and oversee validation protocol execution or validation activities with cross-functional departments.
- Evaluate and analyze qualification data, addressing deviations if necessary.
- Ensure SOPs reflect validated conditions and provide input on change control assessments.
- Assist in the development of validation policies and procedures.
- Interact and guide other departments on validation matters.
- Support department managers in project timelines and resource allocation.
Qualifications
- Bachelor's degree in science (Biology, Microbiology, Biochemistry, Chemistry) or engineering (Electrical, Electronics, Computer Science) or equivalent technology-related field.
- Minimum of 3 years' work experience in a biopharmaceutical or pharmaceutical manufacturing environment, with at least 1 year directly involved in validations.
Position Details
- Type: Full-time
- Hours: Monday through Friday, 8am to 5pm PST, with flexibility as per supervisor.
Compensation
- Competitive compensation package including base salary, performance-based bonuses, and benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
- Annual compensation range: $82,000 - $104,400, based on experience and qualifications.
About Avid Bioservices
Avid Bioservices is a leading clinical and commercial biologics CDMO committed to creating innovative solutions to meet client needs and improve patient outcomes.