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Guerbet is a leader in medical imaging worldwide, offering a wide range of pharmaceutical products, medical devices, digital and AI solutions for diagnostic and interventional imaging, to improve the diagnosis and treatment of patients.

A pioneer since more than 90 years in the field of contrast media, Guerbet is continuously innovating with 9% of revenue dedicated to Research & Development and four centers in France, Israel and the United States.

Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated €817 million in revenue in 2019 with a global workforce of over 2,800 employees.

Achieve, Cooperate, Care and Innovate are the values that Guerbet's employees share and practice every day. Working at Guerbet means playing a unique part in the future of medical imaging. Passionate about its business, the company strive day in, day out to combine performance, quality and sustainable development.

For more information about Guerbet, please go to www.guerbet.com  and follow Guerbet on Twitter @GuerbetGroup

 

Validation Specialist II

OUR NEED:

 We are currently seeking a Validation Specialist, to join and grow within our senior Validation team. This individual will author, execute, and summarize validation protocols. Coordinates and manages validation project execution for equipment, critical utility, and computer related systems.  Ensures protocols, records, and procedures are in compliance with current Good Manufacturing Practices (cGMP) and approved SOPs.  Support investigations for critical equipment, processes, and utilities.

 

YOUR DUTIES:

  1. Development of Verification/Qualification deliverables including but not limited to Requirements Documents, Functional and Design Specifications, Test Protocols (IQ/OQ/PQ), Revalidation (Equipment, and Cleaning) and Summary Reports.
  2. Execution of Test Protocols, including identification and resolution of non-conformances/deviations.
  3. Tracking and managing change control activities for multiple concurrent projects.
  4. Provides technical advice on new equipment and modification to existing equipment to ensure validation/qualification status is maintained in a state of control.
  5. Provides technical assistance and training for personnel.
  6. Recommends changes in policies and procedures, to management, to enhance the company's ability to conform to and maintain compliance with site, corporate and regulatory standards.
  7. Notifies and recommends to management course of action when critical instruments, systems or processes are found to be out of specifications.

 

YOUR BACKGROUND:

Education required/ preferred:

BS degree in engineering/life sciences or equivalent validation experience.

Experience:

2-4 years of validation experience in a pharmaceutical environment.

Experience with any of the following: Parenteral formulation, filling and packaging equipment, thermal mapping, critical utilities (Nitrogen, Compressed Air, Clean Steam, HVAC Validation, Compendia Water Systems), sterilization/depyrogenation, cleaning validation planning and execution.

Preferred Skills/Qualifications:

  • Working knowledge of cGMP, GLP, and FDA regulations. Knowledge of typical pharmaceutical equipment.
  • Possess effective skills for developing, performing, evaluating, troubleshooting for operating systems and controls, or within a specific scientific / technical discipline.
  • Well-developed knowledge of pharmaceutical industry standards and requirements (e.g. cGMPs, GAMP, ICH, ISPE baseline guide, ASTM E2500).
  • Ability to read, analyze, and interpret Validation protocols, SOPs, technical procedures, or governmental regulations.
  • Ability to define problems, collect data, establish facts, and draw valid conclusions from these observations. 

 

 

 

 

WHY GUERBET?

  • Exempt-employee benefits start on start date, non-exempt benefits start a month after hire 
  • Competitive 4% 401K match + 2% profit sharing contribution
  • Tuition reimbursement program for ongoing education 
  • 4 weeks of PTO 
  • Opportunity to collaborate with colleagues around the world!