Equipment & System Validation Specialist

Equipment & System Validation Specialist Req ID #:  99612 Location: 

Laval, Quebec, CA, H7V 4B3 For 70 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

We are seeking for aEquipment & System Validation Specialist for our site located in Laval.

ACCOUNTABILITY

Perform analysis and prepare documentation on compliance requirements of GLP regulated processes, as applied to computerized equipment and systems. Assist and guide system owners, validation directors and system administrators with compliance efforts focusing on standards and established controls.

WORKING ENVIRONMENT

• Telework and on-site alternation;

KNOWLEDGE/SKILLS

• Minimum 3-5 years of experience in validation, computerized systems, ideally in a regulatory environment;

• Bachelor's degree in Natural Sciences or Computer Sciences or any combination of experience and academic background relevant to the position will be considered;

• Knowledge of computerized systems validation in accordance with 21 CFR Part 11 and corresponding OCDE rules (GLP);

• Excellent knowledge of legislation, principles, practices and procedures related to the job;

• Good communication skills, both verbal and written. Intermediate English required.

• Excellent organizational, interpersonal, analytical and problem solving skills;

• Ability to work under time constraints and adapt to change;

• Meticulous and attentive to detail;

• Working knowledge of job-related computer applications;

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 Safety Assessment

Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market.  Each year approximately 120 investigational new drug (IND) programs are conducted in our Safety Assessment facilities. 

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 17,000 employees within 90 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. And in 2019, revenue increased to $2.62 billion.

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 ~85% of the drugs approved by the FDA in 2019.

Equal Employment Opportunity

Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled/Vet.

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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