Validation Engineer

Req ID #:  204192
Location: 

Dublin, IE, D09

For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about.

 

IMPORTANT:   In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process.  Please make sure work history and education are added correctly.   

Job Summary

 

BASIC SUMMARY: 


Day to day duties as Validations Engineer for the Biologics Testing Solutions Division.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES: 

 

  • Writing, reviewing and executing validation documents.
  • Liaising with the relevant Department Manager for the review of validations documents and prioritise validations projects.
  • Liaise with the Validation Project Manager on Biologics Testing Solutions validation projects.
  • Project Manage the full lifecycle for validation projects including but not limited to; delivering on time and to specification ensuring the delivery of a quality validation project within the Biologics business.
  • Responsible for developing, preparing the installation of and revising test validation procedures/protocols in accordance with appropriate regulatory agency validation requirements, corporate, internal company standards and current industry standards.
  • Write or assist in writing of SOPs for Validation Projects.
  • Participate in validation project meetings, workshops, training of staff and production of related documentation.
  • Present validation system programmes at internal and external audits as required.
  • Provide progress reporting and input into established project documentation.
  • Manage direct relationships with key project stakeholders.
  • Perform duties in accordance with Standard Operating Procedures and with the principles of GMP according to the requirements of the assigned task. Ensure that all documentation is accurate and complete. 
  • Report any non-compliance to Quality Assurance, the Validation Manager, and to the relevant Department Manager.
  • Develops and implements solutions to validation issues.
  • Involvement in Lean Six Sigma projects to improve efficiencies in the Biologics Testing Solutions Division. 
  • Any other duties assigned by the Validation Manager as the role of Validations Engineer develops.

 

QUALIFICATIONS:

 

  • Education: **Science Qualification or Equivalent
  • Experience: 2 Years work experience
  • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
  • Certification/Licensure:  
  • Other:

 

PHYSICAL DEMANDS:

 

  • Some light lifting
  • Standing
  • Flu vaccination may be required

 

WORK ENVIRONMENT:

 

  • General Laboratory Environment

Job Qualifications

IMPORTANT: A resume is required to be considered for this position. If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV. 
 

About Microbial Solutions
Our Microbial Solutions business group has a comprehensive portfolio of endotoxin testing, microbial detection and microbial identification products and services is unlike any other, and has been purposefully designed to meet the complex and ever-changing needs of the industry. We help clients to ensure product safety and quality with easy-to-use yet robust testing solutions that satisfy regulatory requirements, support critical decision making and improve operational efficiencies.

 
About Charles River
Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

 

With over 20,000 employees within 110 facilities in 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. 
 

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly supported the development of 86% of the drugs approved by the FDA in 2021.
 

Equal Employment Opportunity
Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status.


If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

 
For more information, please visit www.criver.com.


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