CSV Engineer – Contract C2C jobs – Urgent need

Contract

C2C jobs

Job Role: CSV Engineer
Location- Portsmouth, NH-Onsite
Contract

 

Description:

•     CSV experience of 4+ years

•     Hands on experience in Implementation & Validation of various computerized systems like MES (Syncade) & PLC (COTS)

•     Strong knowledge of Software Development Lifecycle (SDLC), including 21CFR part 11/Annex 11, Data Integrity and computerized system validation requirements.

•     Experienced at working independently as well as in a team-oriented, collaborative environment is essential

•     Author and Execute CSV life cycle documentation.

•     Experience with Risk assessment (ERES, ATRA, DIRA)

•     Extensive understanding of 21 CFR Part 11/Annex 11, GAMP 5, and other regulatory guidance associated with computer/automation-based systems.

•     Manage, document, and assess the software changes throughout the SDLC following Lonza procedures.

•     Experience with Kneat.

•     Strong verbal and written communication skills

•     This role is 100% onsite (preferred). Hybrid is optional.

To apply for this job email your details to Mohankumar@s2ssoft.com