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, CFR Part , and other federal IT regulations.
• Understanding of laboratory operations, data collection, and workflows.

Compensation for the CSV Specialist includes :

• Salary Range : approximately $, - $, annually, commensurate with experience
• Full Benefits : Medical, Dental, Vision, k, PTO, Paid Holidays

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