Systems Validation Specialist - United States
Charles River (company)
For nearly 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.
Provide oversight and implementation of validation activities associated with computerized systems, equipment, processes, test methods, and facilities to ensure compliance with applicable Current Good Manufacturing Practice (CGMP) regulations, Corporate policies, and site Standard Operating Procedures (SOP's). Work closely with the various departments in the design and development of validation protocols to ensure the purpose, testing and intended outcomes are defined and are in compliance with the Master Validation Plan and applicable CGMP requirements.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Prepare Master Validation Process (MVP) documents for computerized system validation,including User Requirements, Functional Specifications, Risk Assessment, Validation Plan,Test Plan, Test Specifications, Test Scripts, and User Manuals.
- Prepare and maintain Installation, Operation, and Performance Qualification (IQ/OQ/PQ) protocols, and subsequent Re-Qualification (RQ) protocols for new and in-use equipment to ensure compliance with site procedures, MVP, and regulatory requirements.
- Prepare test method validation protocols to ensure the testing strategy and acceptance criteria have been defined, and that testing activities associated with the variables applicable to the assay are in compliance with applicable regulatory requirements and site procedures.
- Prepare test scripts comprising formal testing of functional requirements in conjunction with computerized system validation. Oversee test script execution.
- Work with Operations on changes to facilities and validated processes to evaluate the impact to any agreements on file with regulatory agencies to ensure subsequent re-validation activities take place prior to implementation, and proper agency notification can be determined. Participate in meetings associated with the scheduling of these activities to ensure minimal impact to existing operations.
- Provide ongoing MVP and other appropriate validation training to staff.
- Provide ongoing support for Data Integrity projects to identify and safeguard critical data in compliance with regulatory requirements and corporate policies.
- Analyze the effectiveness of assigned validation protocols to assure the processes are reproducible and result in a quality product.
- Organize an efficient method to ensure all requirements of assigned validation protocols are ompleted and that validation efforts are executed in a timely manner.
- Participate in the development of corrective actions as needed for deficiencies that may be uncovered during validation studies in regards to equipment, processes, test methods, facilities computer software/systems, SOPs, and other related issues in order to assure compliance with applicable regulatory requirements/guidelines, procedures, and policies.
- Participate in the development of CAPA’s and assess the effectiveness of the corrective action. Schedule validation project team meetings to assure project milestone schedules are maintained and deliverables satisfy requirements.
- Assist as needed during facility audits by customers and regulatory agencies, and help to resolve internal audit findings and to resolve other quality issues related to validation.
- Perform all other related duties as assigned.
The following are minimum requirements related to the Systems Validation Specialist position.
- Education: Bachelor's degree (B.A./B.S.) or equivalent in a scientific discipline or related field.
- Experience: Minimum of 2 to 4 years computerized system validation related experience in a pharmaceutical, biotechnology and/or biomedical industry. Working knowledge of lab equipment, test method, process, and facility validation in a regulated environment.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Must have excellent oral and written communication skills. Strong documentation development and technical writing skills are critical to this position.
- Certification/License: None.
- Other: Leadership ability, project management, and facilitation skills required. Must be proficient with office software (word processing, spreadsheets, PowerPoint). Must have good interpersonal, organizational, and analytical skills.
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 11,000 employees within 70 facilities in 18 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 2016, revenue increased by 23.3% to $1.68 billion from $1.36 billion in 2015.
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 ~70% of the drugs approved by the FDA in 2016.
For more information, please visit www.criver.com.
Equal Employment Opportunity
Charles River Laboratories, Inc. is an Equal Opportunity Employer M/F/Disabled/Vet