
CSV/GxP Consultant (System Owner/Manager)
Irvine, CA · HybridJobSeen 1 day agoSeen in employer's feed 1 day ago
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Job overview
A pharmaceutical client in Irvine seeks a CSV/GxP Validation Consultant/System Owner to lead system ownership, perform validation on clinical and non‑clinical systems, manage implementations, ensure timely releases, collaborate with vendors, and provide full operational support.
Skills & qualifications
Skills
Qualifications
Full job description
Job Description
A pharmaceutical client in Irvine, CA is seeking a CSV/GxP Validation Consultant/System Owner. This person will ideally be located in Orange County, CA going into the Irvine office 3 days/week. If not local, candidates must be in California and work PST hours (will go onsite to Irvine 3-4 days/quarter). We are looking for someone with strong system ownership who has done the CSV and GxP validation on both clinical and non-clinical system (veeva, egnyte, dot compliance, etc) and has managed implementations from start to finish. This person will be the true system owner/system admin ensuring releases are done on time, working with vendors and truly being the entire "operational support" of the system.
Skills and Requirements
Bachelors Degree 8+ years doing CSV/GxP validation 3+ years of system ownership (either clinical or non clinical systems like Veeva, Egnyte, dot compliance, etc) Local to Irvine, CA (preferred) Excellent written and verbal communication skills
We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].
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