Commissioning, Qualification, and Validation Specialist
6 days ago
We are seeking a highly skilled Commissioning, Qualification, and Validation Specialist to join our team at Experis. As a key member of our CQV team, you will be responsible for ensuring the smooth operation of our manufacturing processes and systems.
Key Responsibilities- Commissioning and Qualification: Perform commissioning, qualification, and validation testing on manufacturing process equipment and instruments to ensure they meet regulatory requirements.
- Documentation and Reporting: Author protocols, initiate controlled documentation, and develop documents such as master plans, design qualification, equipment, facility, and utility commissioning and final reports.
- Client Interaction: Interact with clients to identify CQV needs and work towards solutions that meet schedule, cost, and quality expectations and requirements.
- Project Planning and Execution: Follow project planning, management, and execution schedules to ensure timely completion of projects.
- Equipment Testing and Validation: Test equipment accurately to meet requirements for intended use and investigate failures and deviations.
- Quality Assurance: Analyze and review spare parts lists to ensure they are fit for purpose and review engineering drawings for accuracy.
- System Walk-Downs and Change Control: Perform system walk-downs and make changes using the change control process.
- CAPAs and Maintenance: Assist with Corrective and Preventative Actions (CAPAs) and make recommendations to resolve deficiencies.
- Education: Bachelor's degree in Engineering or related field.
- Experience: 1 year of relevant project experience and 4 years of applicable (Commissioning, Qualification, or Validation) experience or the equivalent combination of education and experience.
- Skills: Clear understanding of cGMPs and pharmaceutical and biopharmaceutical unit operations, ability to apply principles of commissioning and qualification, good analytical, organizational, time management, and problem-solving skills.
Experis is a leading global workforce solutions company that helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills.
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