Position Summary

The contractor in this role will support the implementation and validation of replacement Product Lifecycle Management (PLM) system, including data and records migration from the legacy PLM platform and seamless integration with the Manufacturing Execution System (MES).

This is a project-based role focused on computer system validation (CSV) including documenting user requirements, supporting PLM configuration, and developing User Acceptance Testing (UAT) and GxP system validation deliverables. The role plays a critical part in ensuring compliant, high-quality system adoption and a successful go-live.

Essential Duties & Responsibilities

User Requirements and System Analysis

• Partner with Business Analysts to conduct requirements elicitation sessions with business stakeholders.

• Translate business needs into clear, testable functional requirements, user stories and system requirements.

• Ensure alignment between requirements, system specifications, and PLM configuration.

• Support user readiness and change activities by identifying deltas between current and future state processes.

PLM Configuration Support

• Collaborate with System Administrators to support configuration of PLM workflows, data mapping, roles, permissions, and supporting objects under guidance from system architects.

• Support functional prototypes, system demonstrations, and iterative configuration reviews.

• Participate in configuration review sessions to help identify validation impacts and support readiness for testing activities.

• Work closely with technical and integration teams to ensure PLM configuration aligns with overall system architecture and data models.

User Acceptance Testing (UAT)

• Develop functional test scripts to support UAT and system validation cycles

• Support UAT planning, readiness activities, and execution.

• Assist business testers with issue resolution, defect logging, and evidence collection.

• Track defects, retesting, and resolution through closure.

• Validate that system functionality meets defined requirements and supports intended use.

eSystems / CSV Validation

• Author and maintain validation documentation, including:

o User Requirements Specification (URS)

o Functional and/or Design Specifications (FS/DS)

o Risk assessments in alignment with CSV and CSA principles

o Requirements Traceability Matrix (RTM)

o Test Scripts (IQ/OQ/PQ)

o Test Summary Report / Validation Summary Report

• Ensure validation deliverables comply with internal Quality Management System (QMS) requirements, GxP expectations, and applicable regulatory requirements.

PLM Implementation Support

• Work closely with IT, Quality, and project teams to support a smooth and compliant PLM implementation.

• Partner with Quality and Validation teams to address findings, resolve gaps, and support audit readiness.

• Develop and maintain system documentation, including process maps, work instructions, and job aids.

• Support validation of system integrations, workflows, permissions, and configuration changes.

• Provide functional input to support development of training materials and user guides in collaboration with Training Lead.

Education & Special Trainings

• BS in a computer science, engineering, business or related discipline.

• 3+ years of experience in Computerized Systems Validations (CSV/CSA) with strong emphasis on document authoring.

• Work experience in a regulated environment (cGMP, cGDP and 21 CFR part 11 regulations) preferred.

Qualifications & Experience

• Hands-on CSV/CSA execution experience in a regulated environment

• Experience authoring test scripts/protocols/traceability documentation

• GxP/FDA-regulated systems experience

• Comfortable translating requirements into testing

• Experience with requirements gathering, functional analysis, and system configuration

• Experience supporting QMS/PLM/document management systems

• Prior experience with PLM software implementation and validation

• Knowledge of PLM software (e.g., Agile, MasterControl, etc.)

• Prior experience working with vendors during software implementation projects.

• Working knowledge of UAT planning, testing tools, and defect management.

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