Computer System Validation Engineer
Working Location: MASSACHUSETTS, SOUTHBOROUGH
Are you looking for a company that cares about people’s lives and health, including yours? At Olympus, we help make people’s lives healthier, safer and more fulfilling, every day.
Let’s inspire healthier lives, together.
As a member of the QA/RA Strategy & Execution Team, this position will help with the validation activities for quality business system software. The position will also be responsible to ensure that all assigned software validation projects are running per schedule. Reports to Senior Manager, Business System CSV and works across all groups with the responsibility to maintain business software validation in the Americas. Also works closely with users to gain consensus and ensure compliance with regulations globally.
* Lead and execute the validation and/or qualification aspects of specific QA (IT) projects.
* Draft, review and approve validation documentation including CSV Risk Assessments, change request forms, requirements, validation plans, data migration plans, IQ, OQ, PQ/UAT test protocols, test cases and reports, and requirements traceability matrices.
* Develop test plans, test scenarios and test scripts for the assigned systems. Review and approve test scripts, test results, and defects, using JIRA. Execute and document assigned test scripts in JIRA.
* Work with business users to understand system functionality and help in drafting system requirements/specifications.
* Assign, monitor and review work of external validation consultants.
* Provide guidance and training to off-shore validation consultants on the development and execution of test scripts and other related testing activities.
* Ensure documentation meets quality standards, applicable regulatory compliance, and the Quality Management System.
* Monitor and advise on quality of all deliverables and report to management.
* Review requirements and specifications in medical device environment to determine 21 CFR Parts 11 compliance.
* All other duties as assigned.
* Bachelor’s degree in Computer Science, Quality Sciences, or equivalent discipline.
* Minimum of 5 years of experience supporting or working within a pharma, medical device, or any other regulatory controlled industry.
* Minimum of 4 years of software validation experience.
* Able to travel domestically and internationally.
* Experience working with off-shore validation team preferred.
* Excellent analytical and problem-solving skills.
* Proficient in the use of Information Technology and applications (i.e., MS Office suite of products).
* Experience with Jira, Oracle, SAP, EtQ Reliance or ERP platforms.
* Knowledge of the software development life cycle (SDLC).
* Knowledge of business application testing approaches.
* Knowledge of medical device regulations including 21 CFR Parts 11.
We realize work isn’t just a job to you.
It’s a big part of your life, but not the only part. That’s why we offer competitive salaries, a robust 401(k) program, annual bonus program and comprehensive medical benefits, as well as tuition reimbursement, flexible schedules, parental and adoption leave, on-site services and Colleague Affinity Networks — so you can be ready for where life can take you.
Olympus requires all new hires to be “fully vaccinated” against COVID-19, as defined by the Centers for Disease Control and Prevention (CDC), on or before their first day of work. Individuals who have been offered employment who have a disability, medical condition, or sincerely-held religious belief that prevents them from being vaccinated against COVID-19 are required to request and be granted a reasonable accommodation prior to their first day of work.
Olympus is passionate about the solutions it creates for the medical, life sciences, and industrial equipment industries, as well as cameras and audio products. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping detect, prevent, and treat disease, furthering scientific research, ensuring public safety, and capturing images of the world.
Olympus’ Medical business uses innovative capabilities in medical technology, therapeutic intervention, and precision manufacturing to help healthcare professionals deliver diagnostic, therapeutic, and minimally invasive procedures to improve clinical outcomes, reduce overall costs, and enhance the quality of life for patients. Olympus’ Medical portfolio includes endoscopes, laparoscopes, and video imaging systems, as well as surgical energy devices, system integration solutions, medical services, and a wide range of endotherapy instruments for endoscopic and therapeutic applications. For more information, visit www.olympus-global.com.
Olympus…True To You. True To Society. True To LIFE.
It is the policy of Olympus to extend equal employment and advancement opportunity to all applicants and employees without regard to race, color, national origin (including language use restrictions), citizenship status, religious creed (including dress and grooming practices), age, sex (including pregnancy, childbirth, breastfeeding, medical conditions related to pregnancy, childbirth and/or breastfeeding), gender, gender identity and expression, sexual orientation, marital status, disability (physical or mental) and/or a medical condition, genetic information, ancestry, veteran status or service in the uniformed services, and any other characteristic protected by applicable federal, state or local law.
Posting Notes: || United States (US) || Massachusetts (US-MA) || Southborough ||