Computer System Validation Engineer

*Role : Computer System Validation (CSV) Engineer* *Location : Greater Nashville, TN - (Onsite from day 1)* *Duration : 12 months(Might extend)* *Automation specialization is Mandatory* We are looking for an Automation Validation Engineer to be responsible for the support of automation related Commissioning and Qualification projects. Project activities span GMP and non-GMP systems, commission, automation assembly validation, test qualification, and possible lifecycle support. The role will require effective collaboration and support to functional areas such as Manufacturing, Quality, Process Engineering, Validation, and other applicable stakeholders.Manage URS, FS, test scripts updating customer comments / review cycles. Interpretation of solid models, mechanical drawings, and operational sequences. *RESPONSIBILITIES:* • Compose design specifications and URS development. • Understand the operational details / machine functions / etc. by interpreting solid models and reviewing sequence of operations and Functional Specification Development. • Manage URS and FS, updating customer comments / review cycles. • Work with Mechanical and Controls team members to keep documentation updated. • Customer requirements tracing. • Device assembly and testing of Automation equipment. • Draft Test Scripts. • Execute Test Scripts • Travel (up to 25%) with the team to a customer’s site as needed (majority of the work will be in the Greater Nashville, TN Area) *QUALIFICATIONS:* • Bachelor's degree in engineering (Chemical, Mechanical, Electrical, or Computer Science preferred). • Must have a minimum of 4 years in the medical device industry/GMP experience. • Must have a strong understanding of Quality Management Systems, Gage R&R, Test Method Validation, Process Validation, GMPs, Computerized Systems Validation (CSV) and Good Engineering Practice (GEP), including ISA S88/S95, GAMP, ASTM E2500, ISPE guidance, 21 CFR Part 11, Annex 11, Data Integrity, ISO 13485, etc . • Experience with Automation equipment for device assembly and testing. • Knowledge of GAMP (Good Automated Manufacturing Practices) GMP and GDP. • Ability to compose design specifications and URS development. • Ability to understand the operational details / machine functions / etc. by interpreting solid models and reviewing sequence of operations and Functional Specification Development. • Demonstrate Excellent interpersonal skills with an ability to interact well with a variety of personalities, discipline skills and educational levels. Job Type: Contract Pay: $60.00 - $65.00 per hour Schedule: * 8 hour shift Ability to commute/relocate: * Nashville, TN 37201: Reliably commute or planning to relocate before starting work (Required) Work Location: In person