Location: Central Texas
Experience: 5+ Years
Job Description: Globiox is seeking to add a Computerized Systems Validation Engineer to its team. Globiox is a consultancy headquartered in Austin, TX. We manage numerous validation projects around the country, and specialize in computerized systems validation.
With Globiox, you will be working in a team-oriented environment, with priorities focused on generating innovative solutions to aid our clients. Globiox emphasizes constant communication with your team. The ideal candidate will not only have the technical qualifications, but also be willing to fit within our company culture of team work, communication, and support.
Duties include representing Globiox on CSV projects in the FDA regulated life-sciences industry. The candidate needs an excellent understanding of FDA requirements for computer systems in a regulatory environment, change control methodologies, creating and reviewing validation deliverables, and standard operating procedures.
Validation of enterprise systems.
The candidate should also have excellent understanding of 21 CFR Part 11, GLP, GCP, GMP regulations, GAMP Methodologies and general Software Development Standards.
Desired Skills & Experience:
- Over 5+ years of Computer Validation/CSV experience within the Biotech/Biologics/Pharmaceutical/FDA regulated industries
- Thorough knowledge of cGMP/FDA regulations & work environment
- Creating and Reviewing SOP's, Validation Master Plan, Traceability Matrix, IQ/OQ/PQ, Testing Documents, Data Migration Plans, Test Plans, Test Cases
- Must be willing to travel
- Must have a flexible schedule
- Strong interpersonal skills, coupled with attention to detail, excellent review skills and analytical skills
- Must have strong ability to organize and manage multiple tasks in a fast-paced environment
Highly Desirable: Send us your resume
- Technical degree in related discipline (Computer Engineering, Engineering, Computer Science, etc.)
- Experience validating TrackWise
- Worked in small start ups