Assist in the development, coordination and execution of qualifications/validation protocols for systems governed by federal regulations as applicable in the pharmaceutical industry.
Project Details:
Prepare and execute cleaning, process and packaging validation, and equipment qualification plans and protocols
Write Final Summary Reports that summarize executed qualifications/validations
Coordinate validation related activities in regards to equipment and processes
Job Experience:
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.
Oxford is an Equal Employment Opportunity Employer. All qualified applications will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Oxford will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. Oxford provides supplemental medical (we do not offer major medical), dental, vision, life, and disability benefit plans along with a 401(k) Retirement Savings Plan. Paid holidays based on eligibility and paid sick leave for applicable jurisdiction, as required. Oxford is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. If you need special assistance or an accommodation while seeking employment, please email oxfordbenefitsgroup@oxfordcorp.com. We will make a determination on your request for reasonable accommodation on a case-by-case basis.
