CSV Specialist II

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 Overview

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.

Job Description

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Manage the full lifecycle of validation projects, ensuring timely delivery, meeting specifications, and maintaining quality throughout.

• Prepare clear and concise validation deliverables for computerized systems, including Validation Plans, Requirement Specifications, Configuration Specifications, Risk Assessments, Test Scripts, Traceability Matrices, and Summary Reports.

• Assist system SMEs in the preparation of test scripts comprising formal testing of functional, system and regulatory requirements in conjunction with computerized system validation. Oversee test script execution.

• Manage multiple validation projects simultaneously, ensuring timely completion and effective communication of project timelines and milestones.

• Adhere to pertinent regulatory requirements and departmental policies and procedures [SOPs, safety procedures and biosafety protocols].

• Write or assist in the writing of SOPs as they pertain to computer system validation and data integrity.

• Collaborate with cross functional teams involved in the validation and maintenance of computerized system (e.g. System Owner, IT, QA, Departmental Managers, vendors, etc).

• Provide guidance and support on Computer System Validation (CSV) practices, helping others develop skills and knowledge in regulatory compliance, validation processes, and industry best practices.

• Identify, schedule and track validation project tasks and timelines using appropriate tools.

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

• Schedule validation project team meetings to ensure project milestone schedules are maintained and deliverables satisfy requirements.

• Contribute to the development of corrective actions, as needed, for deficiencies that may be uncovered/observed during validation efforts to ensure compliance with applicable regulatory requirements, guidelines, procedures, and policies.

• Proactively identify opportunities for process enhancements and implement innovative solutions to drive efficiency, quality, and effectiveness, fostering a culture of continuous improvement.

• Serve as the primary point of contact for client and regulatory audits related to computer system validation, resolving or mitigating audit findings related to system validation.

• Assist, as needed, during client and regulatory audits and help to resolve or mitigate audit findings related to system qualification/validation.

• Perform all other related duties as assigned.

QUALIFICATIONS:

• Education: Bachelor's degree (B.A./B.S.) or equivalent in Computer Science, Information Technology, Engineering, Life Sciences, or related field.

• Experience: 5-7 years of experience in computer system validation within a regulated industry (pharmaceutical, medical device, biotechnology).

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

• Certification/Licensure: Certifications like Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or specialized CSV training 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 rate for this role is $95,000 - $105,000 per year. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

Physical Requirements

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. 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 80% of the drugs approved by the FDA in the last five years.

We're committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.

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.

It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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 View email address on click.appcast.io. 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

234326