JMI Laboratories is looking to add an experienced, full-time Computer Systems Validation Specialist to our team.
JMI Laboratories (www.jmilabs.com) is a global leader in the research of antibiotic and antifungal agents, operating as a clinical reference laboratory in support of new drug development studies, clinical trial studies, and antimicrobial surveillance programs.
This is a hands-on position within the quality assurance unit, an independent function that supports the company’s quality systems and monitors studies to assure that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with all Federal, State or other regulatory requirements. The person fulfilling this role should be an independent self-starter and will require expert knowledge of computer system validation methodologies and will provide compliance leadership, direction, and QA oversight of GxP regulated computerized systems.
- Author validation policies and procedures to maintain and monitor for compliance with applicable GxP regulations by applying validation principles such as GAMP5, V-model, Software Development Life Cycle (SDLC), Agile Software Development to both commercially purchased and proprietary software used in GxP activities.
- Maintain awareness of current regulatory trends and their impact on the validation status of computerized systems. Provide interpretation and recommendations on compliance with FDA / EU Regulations regarding CSV related issues.
- Develop and maintain validation documentation such as user requirement specifications (URS), functional requirement specifications (FRS), design specifications, risk-analysis, traceability matrices, installation qualification protocols, operation qualification protocols, performance qualification protocols, validation master plans, and summary reports.
- Design and execution of validation test plans.
- Provide training on systems implementation and validation SOP’s.
- Conducts system compliance risk assessments and 21 CFR Part 11 assessments on new and existing computerized systems.
- Perform impact assessments for system changes through documented change control process and participate in planning and implementation of changes.
- Act as a validation subject matter expert for client and/or regulatory audits or inspections.
- Ability to make decisions within the scope of validation process approach.
- Bachelor’s Degree in Laboratory Science (Microbiology preferred) or a related science field.
- 5+ years’ experience in computer systems validation with demonstrated direct responsibility for validation in biotech / pharmaceutical environment.
- Demonstrated proficiency in communication and working well with others is desired.
- LIMS and/or EQMS experience.
JMI Laboratories is based in North Liberty, IA and offers a competitive salary and benefits package, which includes health, dental, vacation, 401(k) and profit sharing.
If you want to contribute directly to help the world combat infectious diseases, we encourage you to submit your cover letter and resume or email to HR@jmilabs.com.
JMI Laboratories is an equal opportunity employer. No recruiters or agencies please.