
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.
• 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