PLM Windchill SME Consultant (CSV Experience)

Job Title: PLM Windchill SME Consultant (CSV Experience)
Location: Remote
Duration: Contract
Job Description
We are looking for an experienced PLM Windchill Subject Matter Expert (SME) with knowledge of Computer System Validation (CSV) to support Product Lifecycle Management (PLM) and Product Change Management (PCM) processes within a medical device or life sciences environment.
The ideal candidate will have strong knowledge of PLM systems, product configuration, change management, and system testing, along with an understanding of applicable regulatory and compliance requirements.
Key Responsibilities
Support PLM and PCM processes, including Bill of Materials (BOM), product structures, and manufacturing process plans.
Apply knowledge of the Software Development Life Cycle (SDLC), User Acceptance Testing (UAT), and system testing to support PLM system validation activities.
Support change management, configuration management, and document control processes.
Assist with Computer System Validation (CSV) activities to ensure PLM systems meet applicable regulatory and quality requirements.
Support PLM system activities in regulated medical device or life sciences environments.
Ensure alignment with relevant quality and regulatory standards, including ISO 13485, FDA 21 CFR Part 820, and 21 CFR Part 11.
Required Qualifications
Minimum of 5 years of relevant professional experience.
Strong knowledge of PLM systems, preferably PTC Windchill.
Experience supporting PLM and PCM processes, including BOM management, product structures, and process plans.
Understanding of SDLC, UAT, system testing, and CSV principles.
Experience working in a regulated medical device or life sciences environment.
Knowledge of ISO 13485, FDA 21 CFR Part 820, and 21 CFR Part 11.
Strong understanding of change management and configuration control processes.

Work arrangement
Yes