Software Validation Engineer
Job TitleSoftware Validation Engineer
Software Validation Engineer, Philips Healthcare, (Andover, MA , Highland Hts, OH, Best, Netherlands or US Home Based)
To support ongoing Software Validation Program responsibilities within the Diagnostic Imaging (DI) Business Group in order to meet regulatory requirements in the validation of business applications.
Key Areas of Responsibility:
- Lead system qualification effort and be the primary client contact for coordinating work, reporting status, resolving issues, and addressing change requests as they apply.
- Responsible for ensuring the accuracy, completeness and compliance of validation deliverables by reviewing the validation packages. This includes providing oversight and assurance that validation documentation meets FDA regulatory, cGMP/GMP, and internal quality requirements.
- Actively participate in the Validation Life Cycle of regulated projects by developing and driving validation deliverables in accordance with defined procedures, participating in application requirements definition, risk assessments, traceability matrix, validation protocol development, validation testing and deviation management; and working closely with cross-functional project teams across Healthcare in appropriate verification and validation testing requirements.
- Support Quality & Regulatory Validation Operations group in following the established process and procedures for Validation in Healthcare business.
- Provide guidance/feedback to business stakeholders in Validation compliance as per the applicable regulatory requirements and Philips Healthcare policies and procedures.
- Work cross-functionally with IT, and the supporting businesses to implement improvements to computer systems; while adhering to the regulatory validation requirements, company QMS procedures, and industry best practices.
- Serves as an active participant as CSV Subject Matter Expert in internal and regulatory inspections.
- Work independently on and successfully solve problems and complete/qualify a system within given constraint of scope, time and schedule.
- Bachelor's degree (BSc) in engineering or Science discipline; but any advanced degrees are preferable in Quality, Regulatory or Software Engineering.
- 7+ years of consistent experience in IT Software Validation methodology in regulated medical device, pharmaceutical and healthcare industry.
- 5+ years of experience with IT software applications development and SDLC methodologies from requirements to validation (based on SDLC, IEEE and industry best practices).
- Expertise in validation of enterprise wide Quality IT systems using established Computer System Validation (CSV) methodology such as GAMP 5 and FDA guidelines.
- Project Management and Supervisory Experience is a plus
- Knowledge of cGMP and GDP requirements
- Strong background in FDA, ISO and EU regulations for medical devices and healthcare; especially FDA 21CFR Part 820/Part 11, ISO 13485 and EU Annex 1.
- Communicate globally, across teams and programs, from senior executives to administrative support personnel.
- Experience working with remote teams.
At Philips, we are driven by our mission to improve the lives of 3 billion people per year by 2025, and every day we move closer to achieving our goal by creating cutting-edge solutions that lead to confident diagnosis, improved care, and increased quality of life for patients. Thanks to our employees who share our passion for improving lives, we are at the forefront of the Healthcare industry leading in image guided interventions, ultrasound, patient monitoring, cardiology informatics, sleep therapy and respiratory care. Named one of the Top 50 Happiest Companies in America in 2013, we enable our employees to create a legacy in life through their work and support their development through people-centric learning, total rewards and personalized development planning programs.
Here at Philips WE ARE Working Together for a Better Tomorrow:
Philips' dedication to enriching lives is reflected in our company, our solutions, and a commitment to our people. Philips products lead to improved healthcare, faster diagnosis and better patient outcomes. Philips employees change lives every day.
Enjoy endless opportunities to learn, and develop your career in the directions to which you aspire. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have impacted over 200 million lives already. Please help us determine what's next. Your ideas and ability to deliver will help to transform the future of healthcare, and allow you to create your own legacy.
Thanks to our employees, we are at the forefront of the Healthcare industry. Healthcare providers, backed by our many market leading solutions, are able to diagnose confidently, improve care, and increase the quality of life for patients across North America each and every day.
Advance your career in an environment that supports work-life balance, health & well-being and continuous learning. Making a difference begins right here, where you come first.
Find out more info about Philips at www.philips.com/na/careers
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