Systems Validation Specialist

Req ID #:  153593
Location: 

Durham, NC, US, 27703

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

Responsible for performing system validations for GLP regulated systems, in conjunction with Systems Administrators/Owners.  

•    Perform all phases of GLP systems validation processes, including but not limited to: validation plans, development of user requirements, system specifications, test plan and test scripts, regression testing, traceability matrices, summary reports, implementation plans, maintenance plans, retirement plans, and data migration plans.
•    Interact with system users, inSystemsternal and external vendors/developers, Regulatory Compliance personnel, Information Technology personnel, and management, as appropriate.
•    Review and have oversight over change control documentation.
•    Communicate with programmers, vendors, or technical management to verify the completion of technical documentation including System Specifications.
•    Assess the quality and compliance of computerized systems used in a GLP environment.
•    Develop and document the execution of test plans and test scripts for the data collection and management system.
•    Evaluate/confirm test script results in conjunction with the System Administrators.
•    Coordinate system maintenance procedures including, but not limited to, change control, periodic system assessments, recoverability, revalidation, security and operational processes.
•    Perform training in the principles of computerized systems validation for internal site personnel.
•    Develop and maintain SOPs in support of system validation activities and validated systems.
•    Verify the completion of validation tasks according to SOP's.
•    Maintain the local validated systems inventory including High Level Systems documents
•    Manage database for assigning validation/qualification ID's.
•    Achieve and maintain expertise pertaining to issues and requirements relative to the computer validation and assigned project area(s).
•    Act as the Validation Project Manager and System Administrator for site computer system validations or Deputy System Administrator for global computer system validations and maintain validated computer systems through timely change controls, version updates, data transfers, and periodic audits/reviews.

Job Qualifications

 

Education: Bachelor's degree (B.A./B.S.) in biological science, or equivalent.
•    Experience: Three to five years’ experience working in a GLP laboratory or on a project  team.
•    An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
•    Other: Must be well versed in the principles of GLP and be able to train staff in computer validation principles. Must be able to regularly participate in discussions of computer problems and usage with all site personnel. Must be able to frequently document all aspects of System
 
Validations including problem reports and solutions, program usage, supply and material orders, etc. Must have the ability to manage multiple projects.

PHYSICAL DEMANDS:
•    Regularly operates a computer and other office productivity machinery, such as a calculator, copy machine, and computer printer.
•    Must occasionally move about inside the office to access file cabinets, office machinery, etc.
•    Regularly provides information to and receives information from/through various technologies, media, sources and contacts. Must be able to accurately exchange accurate information in these situations.
•    While performing the duties of this job, the employee regularly wears protective clothing (scrubs, lab coats, safety glasses, and gloves).
•    While performing the duties of this job, the employee is occasionally required to work near moving mechanical parts, sharp objects, toxic or caustic chemicals and biohazards, and may be exposed to allergens and/or zoonotic diseases.


WORK ENVIRONMENT:
•    General office working conditions with regular entrance into laboratory areas required.
•    The noise level in the work environment is usually quiet.

 

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. 


Vaccine Mandate
Charles River is a U.S. Federal Contractor.  As a result, we must follow the Presidential Executive Order to mandate vaccinations, and ensure our employees are fully vaccinated against COVID-19 by December 8, 2021.  Our main priority is the wellbeing, health, and safety of our people. We will be requiring proof of vaccination from all employees. 


Anyone with requests for disability-related and/or religious exemptions should contact Talent Acquisition (crrecruitment_US@crl.com) so that information can be provided about the accommodation process at Charles River.

 

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 18,000 employees within 100 facilities in over 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 >80% of the drugs approved by the FDA for the past 3 years.


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, 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.


Nearest Major Market: Durham
Nearest Secondary Market: Raleigh

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