Computer Systems Validation Specialist

Wayne, PA, United States

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.

Job Summary

Responsible for computerized system validation activities within CRL Manufacturing Operations, including, but not limited to, equipment and software and for assisting in the selection and defining specifications such equipment and software. Responsible for maintaining all documentation pertaining to validation activities. Serve as an information resource for validation team members, contractors, and vendors.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Manage the full lifecycle of validation projects including but not limited to delivering on time and to specification ensuring the delivery of a quality validation project at all times.

Write and assist in writing all validation deliverables within the Computer System Lifecycle, e.g. Validation Plans, Summary Reports, Configuration Specifications

Responsible for developing and revising test validation procedures/protocols in accordance with appropriate regulatory agency validation requirements, corporate & site quality management system and current industry practices.

Ensure the Systems Inventory is up to date at all times.

Maintain validation documentation and files including the Master Validation Plan (MVP) in defined locations per approved procedures.

Archive all validation documentation per approved procedures.

Write or assist in the writing of SOPs for the Validation Department.

In collaboration with the technical/lab operations department plan installation, regular maintenance and repair of computerized systems and ensuring appropriate documentation.

Coordinate project meetings, steering committees, workshops and production of related documentation i.e. minutes of meetings, project plans etc.

Train and coach staff in relation to validation projects as required.

Manage cross functional teams involved in the validation project deliverables (e.g. Project Team, IT, Departmental Managers, vendors, etc).

Provide project updates and input into established project documentation.

Effectively communicate project expectations to team members and stakeholders in a timely and clear manner.

Assist other departments in response to their validation requirements as required.

Report any non- compliances of Quality Management System with respect to validation to the Senior Management.

Identify plan and schedule project timelines and milestones using appropriate tools.

Develop and implement solutions to validation issues.

Present validation systems program during internal and external audits.

Perform all other related duties as assigned.

Job Qualifications

Education: Bachelor's degree (B.A./B.S.) or equivalent in computer science, scientific or related discipline.

Experience: 5-7 years related experience in Computer System Validation. Prior experience working in a GxP laboratory is preferred.

An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

Certification/Licensure: Test or validation certification desired.

Other: Comprehensive knowledge of regulatory requirements, including GxPs, 21 CFR Part 11, and Annex 11 as they pertain to computerized systems, is preferred. Excellent organizational and analytical skills and demonstrated ability to shift priorities to meet a constantly changing environment.

Compensation Data

The pay range for this position is $93,000 - $98,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

About Biologics Testing Solutions

With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs. Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.

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 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 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 [email protected]. 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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