Note: The job is a remote job and is open to candidates in USA. United Pharma Technologies hires a PLM Windchill SME Consultant to support and maintain PLM and product configuration processes in the PTC Windchill environment. The role also supports system testing and validation, regulatory compliance, user support, and process improvements in a regulated industry.
Responsibilities
- Support and maintain Product Lifecycle Management (PLM) and Product Configuration Management (PCM) processes within the PTC Windchill environment
- Manage product structures, part management, and Bills of Materials (BOM), including Engineering BOM (eBOM) and Manufacturing BOM (mBOM)
- Support product data management, document management, lifecycle states, versioning, and configuration control activities
- Support engineering change management processes, including Change Requests (CRs), Change Notices (CNs), and Change Tasks
- Apply Software Development Life Cycle (SDLC), User Acceptance Testing (UAT), and system testing principles to support PLM functionality and validation activities
- Develop, review, and execute test scripts, test cases, and test scenarios for PLM system functionality
- Support functional testing, integration testing, regression testing, UAT, and defect management
- Collaborate with business stakeholders, engineering, quality assurance, validation, and IT teams to gather requirements, troubleshoot issues, and resolve functional defects
- Provide subject matter expertise in Windchill workflows, business processes, system configurations, product structures, and user requirements
- Support Computer System Validation (CSV) activities, including validation documentation, requirements traceability, risk assessments, and test evidence, as applicable
- Assist in preparing and maintaining validation deliverables, including User Requirements Specifications (URS), Functional Specifications (FS), test protocols, test reports, and validation summaries
- Support compliance with applicable regulatory and quality requirements, including ISO 13485, FDA 21 CFR Part 820, FDA 21 CFR Part 11, EU MDR, and GxP
- Assist with audit readiness, documentation reviews, change control, and compliance assessments for regulated systems
- Ensure system changes are appropriately tested, documented, reviewed, approved, and implemented
- Provide user support, troubleshoot PLM-related issues, and contribute to process improvements and system enhancements
Skills
- Minimum of 7+ years of overall professional experience in PLM, Windchill, product data management, configuration management, or related areas
- Strong working knowledge of PTC Windchill PLM and associated product lifecycle management processes
- Experience with Product Configuration Management (PCM), part management, product structures, and BOM management
- Knowledge of Engineering BOM (eBOM), Manufacturing BOM (mBOM), and product configuration processes
- Experience supporting engineering change management processes, including Change Requests, Change Notices, and Change Tasks
- Understanding of SDLC methodologies, system testing, UAT, and software validation principles
- Some hands-on experience with Computer System Validation (CSV) in regulated environments
- Experience in the medical device, pharmaceutical, biotechnology, or life sciences industries
- Understanding of applicable regulatory and quality requirements, including ISO 13485, FDA 21 CFR Part 820, FDA 21 CFR Part 11, EU MDR, and GxP, as relevant to the project
- Strong analytical, troubleshooting, communication, and documentation skills
- Ability to work effectively with business stakeholders, quality teams, validation teams, and technical teams
Benefits
- Medical, dental, and vision insurance options are available through a third-party provider; employees are responsible for paying the full cost of their insurance premiums.
- A 401(k) retirement savings plan is available; no employer matching or other employer contributions are provided.
Company Overview
Company H1B Sponsorship