Assist in the development, coordination and execution of qualifications/validation protocols for systems governed by federal regulations as applicable in the pharmaceutical industry.
Prepare and execute cleaning, process and packaging validation, and equipment qualification plans and protocols, Write Final Summary Reports that summarize executed qualifications/validation, Coordinate validation related activities in regards to equipment and processes.
- 5+ years of experience in computer system validation.
- Must have strong Quality and Validation background in CSV.
- Have working knowledge of 21 CFR Part 11, Data Integrity and GAMP 5
- Must have experience in the biotechnology, pharmaceutical or FDA Regulated related industry.
- Bachelor's Degree in engineering, science, or related technology field.
- An existing right to work in the EU required