Job Description Summary

Job Description

P3-14201

• Validation Planning & Execution

• Develop and execute validation protocols (IQ/OQ/PQ) for eDHR systems and related equipment.
• Ensure validation activities meet regulatory standards such as FDA 21 CFR Part 11 and ISO 13485.
• Conduct performance testing and document results to confirm system functionality and reliability.

• System Compliance & Quality Assurance

• Ensure eDHR systems comply with internal quality standards and external regulations.
• Collaborate with Quality Assurance teams to align validation efforts with broader quality goals.
• Participate in audits and provide documentation to support compliance.

• Process & Data Integrity

• Validate that eDHR systems accurately capture and store production data in real-time.
• Monitor data integrity across the manufacturing lifecycle—from raw materials to finished goods.
• Ensure traceability and error-proofing mechanisms are functioning as intended.

• Documentation & Reporting

• Author and maintain validation documentation, including protocols, reports, and SOPs.
• Record and analyze test data to identify anomalies and ensure systems meet specifications.
• Prepare detailed reports for internal review and regulatory submissions.

• Cross-Functional Collaboration

• Work with IT, OT, manufacturing, and quality teams to coordinate validation activities.
• Support changing control processes and ensure validated state is maintained during updates.
• Train and mentor team members on validation procedures and compliance requirements

Qualifications:

• Bachelor’s degree in biomedical engineering, Quality Assurance, Engineering, or Information Technology.
• Hands-on experience with eDHR systems, MES platforms (preferably Apriso), and digital manufacturing environments.
• Experience developing and executing validation protocols (IQ/OQ/PQ) for software systems and equipment.
• Strong understanding of computer system validation (CSV) principles and risk-based validation approaches.
• Skilled in performance testing, data analysis, and reporting to confirm system reliability and compliance.
• Proven ability to ensure system compliance with internal quality standards and external regulatory requirements.
• Knowledge of data integrity, error-proofing, and traceability mechanisms in manufacturing systems.
• Proficient in authoring and maintaining validation documentation, including protocols, SOPs, and test reports.
• Ability to analyze test data, identify anomalies, and ensure systems meet defined specifications.
• Experience preparing regulatory submission documents and internal review reports.
• Cross-Functional Collaboration
• Collaboration skills to work with IT, OT, Manufacturing, and Quality teams.
• Experience supporting change control processes and maintaining validated states during system updates

Required Skills

Optional Skills

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Primary Work Location

Additional Locations

Work Shift