CSV Engineer - Salent Solutions
Newark, NJ
About the Job
Computer System Validation (CSV) Engineer
Pharmaceutical and Biotechnology Projects
Company: Salent Solutions
Location: Greater Newark, NJ area
Compensation: Commensurate with Experience
About this opportunity:
This role will develop and execute CSV documentation, including validation plans, protocols and reports for computerized systems, including equipment control systems, data management systems, and laboratory information management systems.
The CSV Engineer will collaborate with cross functional teams to ensure that computerized systems are designed, installed, and maintained in compliance with GxP guidelines and industry regulations, including 21 CFR Part 11 and GAMP 5. This CSV Engineer will work in a team environment with engineers and designers from partners and clients to provide services. This role has high growth potential in a fast paced, people-focused organization.
What we’re looking for:
Bachelors degree in Engineering, Computer Science, or related field
3 years of experience in CSV in a highly automated pharmaceutical facility
Experience either working in Quality Assurance or closely with QA teams
Familiarity with computerized systems including control systems (Emerson, preferred), data management systems, and laboratory information management systems
Preferred, experience in commissioning and startup of control systems
Life Sciences or Pharmaceutical project experience required
Self-motivated with excellent communication skills to work with all levels of the organization and with external vendors and clients
Exceptional critical thinking, data analysis, and problem solving skills
Organizational ability to manage the overall documentation development and approval process including explanation and justification of document testing, content, and strategy from a quality and regulatory standpoint to facilitate acceptance and approval of the document by required signatories
Ability to adhere with project schedule(s) for all assigned activities
Documenting the planning and design required to support the changes, approvals, and testing
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