Piper Health & Sciences is seeking an experienced Computer Systems Validation (CSV) Specialist to join a rapidly growing life sciences organization in the Muskegon, MI area.
Responsibilities for the CSV Specialist include:
Collaborate with QA leadership in order to develop and implement new, efficient CSV programs for a GLP-regulated environment.
Conduct internal audits/assessments to identify computerized system validation needs, or host and assist in external audits, as needed.
Assist QA with auditing vendors of cGMP related software and hardware and evaluating vendor validation protocols.
Assist with sitewide computer validation projects and perform periodic review of all validated systems.
Develop SOPs/protocols for software and computer validations.
Qualifications for the CSV Specialist include:
5 years of experience in Computer Systems Validations.
Bachelor's degree in relevant field is required.
Knowledge of GxP, GLPs, 21 CFR Part 11, and other federal IT regulations.
Understanding of laboratory operations, data collection, and workflows.
Compensation for the CSV Specialist includes:
Salary Range: approximately $85,000 - $100,000 annually, commensurate with experience
Full Benefits: Medical, Dental, Vision, 401k, PTO, Paid Holidays
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