Share this Job

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

 

Sr. Validation Engineer

OUR NEED:

The Sr. Validation Engineer is a key member of our team, and authors, executes, and summarizes 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 ROLE:

 

  1. Coordinate and execute validation studies, writing protocols, documenting results, and, generate final reports, and summaries of work for release of equipment tested.
  2. Develops and revises new or existing procedures to insure compliance to cGMP, GLP, and FDA regulations.       
  3. Conducts special projects as directed by management.
  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:

2-6 years of validation experience in a pharmaceutical environment.

 

Preferred Skills/Qualifications:

  • Working knowledge of cGMP, GLP, and FDA regulations. Knowledge of typical pharmaceutical equipment.
  • Ability to read, analyze, and interpret Validation protocols, SOPs, technical procedures, or governmental regulations. 
  • Ability to write protocols, reports, business correspondences and procedures.  All communication must be in English, using good grammar and appropriate vocabulary.
  • Ability to comprehend and apply principles of calculus, modern algebra, and advanced statistical theory.
  • Ability to define problems, collect data, establish facts, and draw valid conclusions from these observations. 
  • Must have a working knowledge of the fundamentals of steam sterilization, cleaning validation, and equipment qualification.

Skills/Competencies:

 

  • Candidate should possess experience in laboratory systems, particularly those with computer controlled functions, and cleaning and sterilization process validation.
  • Self-motivated, energetic, enthusiastic, and team oriented.
  • Requires the ability to apply analytical and scientific principles for solving problems and for properly designing validation test cases.
  • Must have a demonstrated comprehension of high level mathematics (i.e., calculus and/or statistics), and technical writing. 
  • Candidate must have excellent computer software usage skills including, but not limited to MS Word, MS Excel, and MS Access. 

Other Skills:

  • Candidate must possess personal drive and the ability to schedule work assignments so that they are concluded in a timely, complete, and error-free manner with the highest level of accountability 
  • Effective communication with both team members and other plant support groups.