PSC Biotech is one of the world's largest consulting firms in the pharmaceutical and biotechnology industry. Currently, we are looking for a Computer System Validation Engineer (CSV) in Orange County, CA. This is an Evergreen Requisition solely used to collect applications.
The Candidate will have 1+ years of experience in CSV or Manufacturing/Lab Equipment Qualification
Responsible for authoring, editing, and executing validation protocols (IQ/OQ) or test scripts.
Collaboration with validation documents; design and execution: Validation Plan, Requirements, Roles & Responsibilities, Design & Configuration Specs, Test Plan & scripts, Protocols, SOP plan, Impact-assessment, Specific Site specifications, CSQ audit, Deployment, Training Plan, BCP
Experience in a GxP environment is a MUST
Prefer knowledge of FDA regulations, such as 21 CFR Part 11
Bachelors Degree in science, engineering, or similar field
Experience working in FDA and SOX regulated environment is required.
Ability to work as a team player in a consulting environment.
Proficiency with MS Office tools
Documentation management and excellent documentation writing skills.
No C2C / No Third Party Resumes
**An Evergreen Requisition is an advertisement for positions that PSC Biotech hires for throughout the year.** It is a way for PSC Biotech to build a database of qualified, interested individuals for a particular job function so that when there is a need to fill that type of role, the hiring process will be faster. By applying to an Evergreen Requisition, you are expressing your interest for a particular job function within the PSC Biotech divisions. In addition to submitting your resume to an Evergreen Requisition, we encourage you to continuously visit our Careers website for new opportunities.Please be mindful ofthe geographic locations you would like to consider. *