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Capgemini

Global consulting, technology services, outsourcing

Commissioning & Qualification Engineer

Regulatory & Quality (Life Sciences)Posted on Nov 12
Full-timeHopkinsville, KY, USA

About the Job

Requirements

  • A bachelor's degree in engineering, Life Sciences, or a related field is required.
  • Three to five years of experience in equipment qualification or validation in a regulated industry such as pharmaceuticals, life sciences, or MedTech is required.
  • Strong knowledge of installation, operational, and performance qualification processes and regulatory standards is required.
  • Analytical and problem-solving skills are required.

Responsibilities

  • Develop, review, and execute Installation Qualification protocols to verify the proper installation of equipment and systems.
  • Ensure accurate Installation Qualification documentation, protocol approvals, and compliance with regulatory requirements.
  • Review Installation Qualification results and prepare summary reports.
  • Develop, review, approve, and execute Operational Qualification protocols and test plans.
  • Verify equipment functionality, calibration, and operational performance.
  • Identify, document, investigate, and resolve deviations, and re-execute failed tests as needed.
  • Ensure training completion and maintain compliant Operational Qualification documentation.
  • Prepare Operational Qualification reports and qualification summaries.
  • Develop, review, approve, and execute Performance Qualification protocols.
  • Perform process verification to confirm consistent performance under routine operating conditions.
  • Ensure Performance Qualification training completion, resolve deviations, and document qualification outcomes.
  • Prepare final Performance Qualification reports and qualification documentation.
  • Maintain qualification protocols, reports, and validation records.
  • Ensure compliance with Good Manufacturing Practice, Good x Practice, FDA, ISO, and other applicable standards.
  • Support audits, change controls, corrective and preventive action activities, and cross-functional qualification projects.

About the Company

Capgemini

Global consulting, technology services, outsourcing

Capgemini provides consulting, technology services, and outsourcing to help organizations transform digitally. Its offerings include strategy and transformation consulting, system integration, application development, IT infrastructure management, and managed IT operations. It differentiates itself with a global presence in over 50 countries and a focus on applying AI, cloud, and cybersecurity to real business problems. Its goal is to help clients navigate digital transformation and improve efficiency and innovation through tailored, contract-based or managed services.

Company size
10,001+
Company stage
IPO
Headquarters
Paris, France
Founded
1967

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