[Remote] PLM Windchill SME Consultant

Note: The job is a remote job and is open to candidates in USA. United Pharma Technologies is seeking a PLM Windchill SME Consultant to provide expertise in Windchill PLM and product configuration management. The role supports product data and engineering change processes, testing and validation, regulatory compliance, audit readiness, and collaboration across engineering, IT, quality, and business teams.

Responsibilities

• Provide subject matter expertise in PTC Windchill Product Lifecycle Management (PLM) and Product Configuration Management (PCM)
• Support product structures, part management, and Bill of Materials (BOM), including Engineering BOM (eBOM) and Manufacturing BOM (mBOM)
• Manage product data, document control, lifecycle states, versioning, and configuration management activities
• Support engineering change management processes, including Change Requests (CRs), Change Notices (CNs), and Change Tasks
• Apply knowledge of the Software Development Life Cycle (SDLC), User Acceptance Testing (UAT), and system testing to support PLM functionality and system validation
• Develop, review, and execute test scripts, test cases, and test scenarios for functional, integration, regression, and UAT testing
• Support defect management, troubleshooting, system enhancements, and resolution of functional issues
• Assist with Computer System Validation (CSV) activities, including requirements traceability, risk assessments, validation documentation, and test evidence
• Prepare and maintain validation deliverables, including User Requirements Specifications (URS), Functional Specifications (FS), test protocols, test reports, and validation summaries, as required
• Ensure compliance with applicable regulatory and quality standards, including ISO 13485, FDA 21 CFR Part 820, FDA 21 CFR Part 11, EU MDR, and GxP requirements
• Collaborate with engineering, IT, quality assurance, validation teams, and business stakeholders to support compliant system changes and process improvements
• Support audit readiness, change control, documentation reviews, and user support activities

Skills

• Minimum of 7+ years of overall experience in PLM, PTC Windchill, product data management, configuration management, or related areas
• Strong hands-on experience with PTC Windchill PLM and product lifecycle management processes
• Experience with Product Configuration Management (PCM), part management, product structures, and BOM management
• Good understanding of eBOM, mBOM, product configuration, and engineering change management processes
• Experience with Change Requests (CRs), Change Notices (CNs), and Change Tasks
• Knowledge of SDLC, UAT, functional testing, integration testing, regression testing, and software validation principles
• Some hands-on experience with Computer System Validation (CSV) in regulated environments
• Experience in medical device, pharmaceutical, biotechnology, or life sciences industries
• Understanding of regulated quality systems and compliance requirements, including ISO 13485, FDA 21 CFR Part 820, FDA 21 CFR Part 11, EU MDR, and GxP, as applicable
• Strong analytical, troubleshooting, communication, documentation, and stakeholder management skills

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

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