Commissioning and Qualification Specialist

4 days ago


Indianapolis, Indiana, United States Project Delivery Partners Full time
Main Responsibilities

As a Commissioning and Qualification Specialist, you will be responsible for ensuring the smooth execution of commissioning and qualification activities for our clients in the biopharma and pharmaceutical industries.

Key Tasks
  • FATs and Walk-Downs: Attend and support the execution of equipment Factory Acceptance Tests (FATs) and conduct walk-downs of mechanically complete systems to verify installation compliance with design and client requirements.
  • Documentation and Communication: Clear communication of defects and punchlist items to the General Contractor and subcontractor, and verification and approval of rectification of defects.
  • Design Verification: Verification of the as-built design documents, including marking updates to the drawing during walk-down and raising and closeout of Change control documentation.
  • Commissioning and Qualification: Execution of Design Qualification, Installation Verification, and Operational Verification, including verification of documentation, tagging, and spare parts.
  • Schedule Management: Compliance with schedule, including completion of tasks in a timely fashion, reporting progress, and identification and early resolution of schedule risks.
  • Technical Stewardship: Troubleshooting and resolving issues, discussing and resolving deviations, changes, design issues, and test failures with manager and subject matter experts.
  • Safety Compliance: Preparation and review of effective risk assessments and method statements, ensuring safe handover of systems, and reporting and investigation into safety incidents.
Key Performance Indicators

As a Commissioning and Qualification Specialist, you will be measured on your ability to:

  • Manage commissioning and qualification activities to meet schedule and quality requirements.
  • Ensure compliance with safety and quality standards.
  • Provide clear and effective communication to stakeholders.
  • Identify and resolve technical issues in a timely manner.
Ideal Background

We are looking for a highly skilled and experienced Commissioning and Qualification Specialist with a strong background in commissioning, qualification, and quality aspects of biopharma or pharmaceutical manufacturing.

  • Education: Minimum BS or equivalent in Engineering or Science, preferably in Chemical, Mechanical, or Pharmaceutical Engineering.
  • Experience: Minimum 3 years of experience in commissioning and qualification, with a strong understanding of engineering disciplines and quality aspects.
  • Languages: Fluent in English, with excellent communication and writing skills.


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