Overview
On Site
Full Time
Skills
MES
Programmable Logic Controller
COTS
Software Development
Data Integrity
Documentation
Computerized System Validation
Risk Assessment
GAMP
Management
Software Development Methodology
Communication
Job Details
Responsibilities:
- 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.
- Experience working independently as well as in a team-oriented, collaborative environment is essential.
- Author and Execute CSV life cycle documentation.
- CSV experience of 4+ years.
- 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.
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