Software Validation Engineer - 21 CFR Part 11（到期)

GDI Communications Inc. is currently seeking a Software Validation Engineer based in Aichi, Japan, for work at a leading pharmaceutical label printing and labeling machine manufacturer. The Engineer will work on a team to design, develop and implement the 21 CFR Part 11 systems and components for onsite machines and operation infrastructure, manufacturing equipment, and computerized systems.

This position will start remote and transition to onsite once the site reopens.

Responsibilities of this position:
- Responsible for programming/development/implementation/operation of all 21 CFR Part 11 related systems and operations. (See "Related Operations" below)
- Ownership of all lifecycle deliverables in the qualification of equipment and full CSV for single and multi-user computerized systems

21 CFR Part 11 Related Operations:
- Requirements & Test Validation
- Testing and Validation Traceability
- Audit Trail
- Controlled/Secure Access
- Electronic Signatures
- FDA Compliance Security
- FDA Compliance Workflow

Required Skills:
- BS in Engineering/Computer Science (or equivalent) & 3 years of exposure in working experience in a pharmaceutical production environment
- Review and approval understanding of computer system validation concepts, lifecycle, and documents (VMP, URS, IQ, OQ, SOPs, etc.)
- Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment, and instrumentation within the pharmaceutical industry
- cGMP’s regulations and 21 CFR Part 11 knowledge and experience

Programming Skillsets & Knowledge:
- Windows Server 2000
- C#, C++, etc.
- SQL Server
- Visual Basics (Studio)
- Siemens PLC