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
Develop and manage validation and qualification activities associated with computerized systems to ensure compliance with applicable GMP regulations, corporate policies, and Standard Operating Procedures (SOPs).
Essential Duties And Responsibilities
- Write, revise, and oversee the approval of all required validation deliverables including: User Requirements Specification, Validation Plan, Functional Specification, Risk Assessment, Test Plan, Test Scripts, Traceability Matrix, Installation and Operational Qualification (IOQ) protocols, Validation Summary Report, and System Commissioning Memo.
- Collaborate with System Owners, Management, Marketing, IT, and Quality Assurance to develop user requirements, system requirements, and specifications in conjunction with the validation of Custom Software (GAMP Category 5) and Commercial Off-The-Shelf (COTS) (GAMP Categories 3 and 4) computerized systems.
- Develop, supervise, and review the execution of formal test scripts.
- Assist in developing Standard Operating Procedures (SOPs), training materials, and user manuals.
- Plan and prioritize validation projects and tasks to ensure timely completion to meet project timelines.
- Become a Subject Matter Expert (SME) in the processes and software supporting our Microbial Identification Business main technologies, including DNA Sequencing, MALDI-TOF Mass Spectrometry, and Laboratory Information Management Systems (LIMS).
- Provide ongoing support for data integrity projects to identify and safeguard critical data in compliance with regulatory requirements and corporate policies. Facilitate process understanding by generating process maps for internal business workflows.
- Become a Subject Matter Expert (SME) in relevant computerized system validation technologies, including the corporate Master Validation Process (MVP), Good Automated Manufacturing Practice (GAMP), Software Development Life Cycle (SDLC), Data Integrity, MHRA ALCOA+, and FDA 21 CFR Part 11 regulations for electronic records and signatures.
- Perform all other related duties as assigned.
Job Qualifications
- Bachelor's degree (B.A./B.S.) or equivalent in a Life Sciences, Computer Sciences, Information Technology, or related field.
Experience
- Minimum of 1-2 years experience in a computer system validation or software testing within pharmaceutical, biotechnology, biomedical, or related industry.
- Familiar with 21 CFR Part 11, ALCOA+, and EU Annex 11.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
Skills And Abilities
- Strong documentation development and technical writing skills
- Effective verbal communication
- Proven analytical and problem solving
- Project management; attention to detail and excellent organizational skills
- Adaptable
- Ongoing commitment to learning
- Excellent collaborator
Physical Demands
- Must regularly operate a computer and occasionally operate other office productivity machinery such as a printer or scanner.
- Must regularly communicate with employees/customers; must be able to exchange accurate information.
- Must be able to regularly read, perform measurements, understand, and verify scientific text and data.
- On average, will sit 6 hours a day but on occasion could remain seated the entire day.
- Must be capable of working in clean room areas, which will require specialized gowning and clean room training.
- Must occasionally move about inside the office to access file cabinets, office machinery, etc.
Work Environment
- General Manufacturing areas and office working conditions
- The noise level in the work environment ranges from quiet to moderate.
- May occasionally be required to wear protective clothing and equipment when performing certain tasks in the laboratory.
Compensation Data
The pay range for this position is $61,500 - $72,300. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, and location.
Competencies
Lead - We lead when we advocate our purpose and model our values, when we deliver innovation, when we embrace change, and when we appreciate and celebrate the great work of others.
Care - We show we care when we respect each other, our animals and the communities where we work and live, when we create a positive healthy workplace, when we are mindful of our compliance standards, and when we choose to do the right thing.
Collaborate -We collaborate when we partner with each other and promote teamwork, when we communicate clearly and effectively across the hall or around the globe, and when we welcome all forms of diversity and encourage inclusiveness.
Own - We act like owners when we hold ourselves accountable for our actions, when we respond to internal and external client needs with speed and accuracy, when we set and achieve meaningful goals, and when we strive towards continuous improvement.
About Corporate Functions
The Corporate Functions provide operational support across Charles River in areas such as Human Resources, Finance, IT, Legal, Sales, Quality Assurance, Marketing, and Corporate Development. They partner with their colleagues across the company to develop and drive strategies and to set global standards. The functions are essential to providing a bridge between strategic vision and operational readiness, to ensure ongoing functional innovation and capability improvement.
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 worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past 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 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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