Commissioning and Qualification Specialist
4 days ago
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.
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.
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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