Job Description

This is a remote position.

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, employing a global team of skilled professional and experts that span across strategically located offices in the United States, Europe, Asia, and the Middle East. PSC operates in 52 countries globally and has served thousands of clients to date.

We focus on providing quality consulting services to ensure our client’s success. PSC provides cost-effective solutions, while providing exceptional technical capabilities and customer service to our clients for all projects ranging from supplier quality audits to greenfield projects. We understand that the world of life science is evolving rapidly, and we must continue to offer new products and services to meet our customer’s expectations.

We are looking for a junior to mid-level Computer Systems Validation Engineer.

RESPONSIBILITIES

• Provide CSV services for an Empower Reports project
• Write Validation Protocols such as IQ, OQ and PQs
• Execute Validation Protocols such as IQ, OQ and PQs to ensure compliance and adherence with applicable guidelines
• Review and modify Standard Operating Procedures (SOPs)
• Generate test procedures to validate new or previously unvalidated processes
• Write risks assessments and applicable test scripts according to GLP and 21 CFR Part 11 compliance guidelines and the Validation Master Plan.
• Prepare validation summary reports for executed protocols.
• Communicate Computer System Validation approaches and requirements during planning/audits.

Requirements

• Minimum Bachelor's degree in Engineering (Chemical, Biomedical, Mechanical, etc.), Computer Sciences, or Life Science major (Biochemistry, Chemistry, Pharmacy, etc.) 
• 2-6 years of CSV experience
• Experience with Empower is strongly preferred
• Demonstrated knowledge of Corrective and Preventive Action
• QC Lab instruments Qualification/Validation
• Experience with Chromatography Data Systems
• Experience writing and executing final reports, function requirements specification, IQ, OQ, PQ, SOPs, user requirement specification, validation plans, risk assessments, summary reports, etc.
• Requirements Traceability Matrix knowledge
• Experience with and understanding of Risk-Based CSV – GAMP 5
• Demonstrated understanding of Software Development Lifecyle
• User Acceptance Testing experience