
Equipment Qualification Engineer
Are you a highly motivated engineer with a passion for ensuring the safety and efficacy of pharmaceutical manufacturing equipment? Look no further! Novartis is seeking an experienced Equipment Qualification Engineer to join our dynamic team. As a global leader in the healthcare industry, we are dedicated to improving and extending the lives of patients worldwide. We are looking for a detail-oriented individual with a strong technical background and a keen eye for quality to drive our equipment qualification processes and ensure compliance with regulatory standards. If you are ready to make a meaningful impact on the healthcare industry, apply now and become a part of our diverse and innovative team at Novartis.
- Develop and implement equipment qualification strategies and protocols in compliance with regulatory standards and company policies.
- Conduct risk assessments and gap analyses to identify potential areas for improvement in equipment qualification processes.
- Collaborate with cross-functional teams, including Quality Assurance, Engineering, and Manufacturing, to ensure equipment qualification activities are executed effectively and efficiently.
- Review and approve equipment qualification documentation, including protocols, reports, and change controls, to ensure accuracy and completeness.
- Identify and troubleshoot equipment qualification issues, and implement corrective and preventative actions to address any discrepancies.
- Maintain a thorough understanding of current regulatory requirements and industry standards related to equipment qualification.
- Provide technical support and guidance to other departments regarding equipment qualification and validation activities.
- Develop and maintain equipment qualification schedules to ensure timely completion of all activities.
- Monitor and analyze equipment performance data to identify trends and implement improvements to optimize equipment performance and reliability.
- Train and mentor team members on equipment qualification processes, procedures, and best practices.
- Participate in internal and external audits to ensure compliance with regulatory requirements and company standards.
- Continuously identify opportunities for process improvement and lead initiatives to drive efficiency and effectiveness in equipment qualification processes.
- Communicate effectively with all stakeholders, including management, team members, and external partners, to provide updates on equipment qualification activities and escalate any issues or concerns.
- Stay up-to-date on industry advancements and trends in equipment qualification and apply them to enhance current processes and procedures.
- Foster a culture of quality and safety by promoting adherence to regulations and standards, and encouraging a proactive approach to equipment qualification.
Bachelor's Degree In Engineering, Preferably In Mechanical Or Electrical Engineering.
Minimum Of 3 Years Of Experience In Equipment Qualification Within The Pharmaceutical Or Biotechnology Industry.
Knowledge Of Gmp Regulations And Experience With Regulatory Inspections.
Strong Understanding Of Equipment Qualification Processes, Including Iq, Oq, And Pq.
Excellent Project Management Skills And Ability To Work Cross-Functionally With Various Teams.
Quality Assurance
Process Improvement
Project Management
Data Analysis
GMP Knowledge
Technical Writing
Risk assessment
Regulatory compliance
Problem-Solving
Equipment validation
Test Protocol Development
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Teamwork
Active Listening
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Equipment Qualification Engineer in East Hanover, NJ, USA is between $85,000 and $120,000 per year. This range can vary depending on factors such as the specific industry, experience level, and company size. Some companies may offer higher salaries or additional benefits such as bonuses or stock options.
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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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