Product Software Engineer - V&V Engineer
CapgeminiAbout the role
Description
About the job you’re considering
General Project Support
·Attend Weekly Project Meetings
·Attend Daily Construction Meetings
·Attend Monthly EH&S Safety Meeting
·Generate Work Orders
·Generate Memos / Interoffice Correspondence
·Generate Meeting Minutes
Generation and Modification of project lifecycle documentation for LA Plant Site.
o User Requirement Specifications
o Functional Specifications
o Design Specifications
o SOPs
o Management of Change (MOC)
o FMEA
o HAZOPs
o Risk Assessments
o Gap Assessments
o Project Closeout Documentation
o Turnover Package Generation
o Project Change Requests
Management of Project Change Control Records (PRs)
o Generate/Initiate
o Manage
o Close
Support Takeda and A/E Firm in Project Design
o Conceptual Design
o Basic Design
o Detailed Design
o Design Review
Construction Activities
o Generate and Manage Safety Management Plans and Documentation
o Disruptive Construction Activity Requests
o Job Hazard Analysis
o Lockout Tag Out Plan
o Hot Work Permitting
o Permit to Work
o Detour Plans
o Construction Signage
o Plant-wide Communications
o Generate and Manage Quality Management Plans and Documentation
o Construction Control Plan
o Assist in site supervision of construction personnel.
Manage Installation and Operational Commissioning
o Author and Approve
o Execution
o Function Testing
o BOM Updates
o PM Generation
o Asset Lifecycle
o Drawing Updates
o Support site acceptance testing to review system documents and functions during SAT.
o Summary Report
Manage Installation, Operational, and Performance Qualification
o Author and approve.
o Develop and execute qualification protocols.
o Assist with any deviation resolution and handling.
o Execution
Summary Report Training and Documentation
o Train personnel on the operation of the Fractionation process, and related procedures
o Create comprehensive documentation of all validation activities.
Risk Assessment and Mitigation
o Identify and assess potential risks to product quality and patient safety.
o Develop mitigation strategies and contingency plans.
Change Control
o Manage change control for any modifications or updates to the equipment or processes.
Quality Audits
o Conduct internal and external audits to ensure compliance with quality standards and regulations.
Start up support.
o Start up support for process equipment and facility as required.
Your role
VALIDATION SUPPORT
Installation Qualification
o Equipment installation verification and confirmation that equipment is installed in
Accordance with manufacturer's specifications.
o Document equipment installation and location.
Operational Qualification
· Equipment functional verifications under operational conditions.
· Conduc
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