
Site Equipment & CQV Lead
Welcome to Novartis, a global pharmaceutical company dedicated to improving lives through innovative medicines and treatments. We are seeking a highly qualified and motivated individual to join our team as the Site Equipment & CQV Lead. In this role, you will be a crucial member of our site team, responsible for the management of equipment and the commissioning, qualification, and validation (CQV) activities across our site. As a leader in our organization, you will have the opportunity to drive success and make a meaningful impact on patients around the world. Join us and be a part of our mission to reimagine medicine.
- Manage and oversee all equipment and machinery at the site, ensuring they are properly maintained, calibrated, and in compliance with regulatory standards.
- Develop and implement strategies for the commissioning, qualification, and validation of equipment and processes at the site.
- Collaborate with cross-functional teams to ensure timely and successful completion of CQV activities.
- Monitor and track equipment performance and work with relevant departments to troubleshoot and resolve any issues.
- Conduct risk assessments and develop mitigation plans to ensure equipment reliability and compliance.
- Create and maintain all necessary documentation related to equipment and CQV activities, including protocols, reports, and standard operating procedures.
- Train and mentor team members on equipment operation, maintenance, and CQV processes.
- Oversee the budget and resource allocation for equipment and CQV activities.
- Stay up-to-date with industry developments and regulations related to equipment and CQV, and implement necessary changes to ensure compliance.
- Foster a culture of continuous improvement and identify opportunities for optimization and efficiency in equipment and CQV processes.
- Represent the site equipment and CQV function in internal and external audits and inspections.
- Lead by example and promote a safe working environment, adhering to all safety regulations and procedures.
- Collaborate with global teams to share best practices and drive consistency across sites.
- Act as a key point of contact for any equipment or CQV-related issues or inquiries from stakeholders.
Excellent Communication And Interpersonal Skills, With The Ability To Effectively Collaborate With Internal And External Stakeholders.
Bachelor's Degree In Engineering, Pharmaceutical Science, Or Related Field
Minimum Of 5 Years Of Experience In Site Equipment And Cqv (Commissioning, Qualification, And Verification) In A Pharmaceutical Or Biotech Industry
Extensive Knowledge Of Gmp (Good Manufacturing Practices) Regulations And Validation Principles
Strong Project Management Skills With Experience Leading Cross-Functional Teams
Quality Assurance
Project Management
Validation
Troubleshooting
Root Cause Analysis
Team Leadership
Risk assessment
Documentation management
GMP compliance
Commissioning
Equipment Qualification
Communication
Emotional Intelligence
Leadership
Time management
creativity
Critical thinking
Attention to detail
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Site Equipment & CQV Lead in Indianapolis, IN, USA is $80,000-120,000 per year. However, this can vary depending on factors like years of experience, education level, and specific job duties. Additionally, the size and type of company can also impact salary range. It is recommended to research the specific company and job posting for more accurate salary information.
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Novartis AG develops, manufactures, and markets healthcare products. It operates through the following segments: Pharmaceuticals, Alcon, Sandoz, Vaccines & Diagnostics, and Consumer Health. The Pharmaceuticals segment provides patent-protected prescription medicines. The Alcon segment offers surgical, ophthalmic pharmaceuticals, and vision care products. The Sandoz segment provides generic pharmaceuticals. The Vaccines & Diagnostics segment provides human vaccines and blood testing diagnostics.

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