Computer Systems Validation Specialist

Computer Systems Validation Specialist Req ID #:  61746 Location: 

Shrewsbury, MA, US 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. Job Summary We are seeking a Computer Systems Validation Specialistto support our Biologicsbusiness in Shrewsbury, MA.

The following are responsibilities related to theComputer Systems Validation Specialist:

• 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, and Change Control.

• When assigned a System Administration role, manage the ongoing computer system administration activities such as user access security, periodic system review, computer system incident resolution and change control.

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

• Maintain appropriate validation documentation and files according to GxP retention and retrieval requirements for the system.

• Write or assist in the writing of SOPs for the CSV related topics and systems.

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

• Coordinate validation project meetings, maintaining minutes of meetings, project plans etc.

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

• Train and coach staff in relation to validation projects 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.

The following are minimum qualifications related to theComputer Systems Validation Specialistposition:

• Bachelor’s degree (B.A./B.S.) or equivalent in computer science, scientific or related discipline.

• 5 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, Part 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.

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 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 2018, 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

Nearest Major Market: Worcester

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