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Sr. IT Validation Engineer, CyberSecurity (Remote, MA OR MN) Job

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Date: Jul 14, 2021

Location: Marlborough, MA, US, 01752

Company: Boston Scientific

Additional Locations: US-MN-Arden Hills

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.


About the role:
Boston Scientific is seeking a Sr. IT Validation Analyst to be part of the Global IT Cybersecurity Org IT Governance Risk and Compliance team. This individual will support all Boston Scientific divisions (globally) with the responsibility overseeing processes to assure existing and new enterprise IT systems meet Boston Scientific’s cybersecurity, privacy and risk requirements.
The Sr. IT Validation Analyst role should have the ability to work closely and collaborate with various business partners including IT, QA, Business customers and vendors. In addition, this role will support QA review/oversight for GxP computer systems used in support of GMP activities. This position will provide the assigned level of systems compliance support and validation oversight for validation and maintenance of electronic systems. 


role can be remote or hybrid in a MN or MA site location

Your responsibilities will include:
•Provide compliance support for the validation and maintenance of electronic systems in accordance with computer system validation (CSV) procedures and GxP regulatory requirements (i.e. 21 CFR Part 11)
•Supports the interpretation of CSV regulations, guidelines and GxP practices and meets regulatory compliance and corporate business requirements
•Supports internal and external audits of electronic systems to verify that systems are validated and maintained in a validated state in accordance with standards and regulatory requirements such as 21 CFR Part 11, Annex 11, etc.
•Support updates to CSV Policies & Standards, including required deliverables such as Validation Plans, Requirements, Test Scripts, Trace Matrices, Validation Summary Report, etc. associated with the validation and maintenance of computerized systems
•Provide updates to management on projects, health of the CSV process and communicate risk-based escalation issues, when applicable
•Support resolution of CSV deviations/errors and provide compliance oversight to software validation projects
•Support the development of training materials, related to the validation of GxP computer systems and/or the use or administration of validated systems. 
•Liaises with IT and other cross-functional business teams for issue management and general IT compliance support.
•Participate in Governance Risk and Compliance initiatives as they arise, including awareness activities and new priority regulation initiatives.
•Perform ongoing research and offer recommendations for new tools/products to ensure they align with the overall Cybersecurity strategy.


Minimum Qualifications:
•Bachelor’s Degree and 3 to 5 years of relevant, practical experience in Quality Assurance and the manufacture or pharmaceutical products.
•Experience writing or interpreting technical and high-level risk reports.
•Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members
•Demonstrated, hands-on, applied knowledge and understanding of applicable GxP or regulatory authority regulations and guidance related to CSV (such as 21 CFR Part 11, Annex 11, etc.) activities and compliance
•Excellent verbal and written communication and skills    
•Strong knowledge of architectural principles, frameworks, design patterns and industry best practices for design and development preferred
•Exceptional problem-solving skills
•Strong team skills with ability to listen and build consensus and collaborate with business, IT and Cybersecurity groups.
•Ability to multi-task, and the ability to coordinate and manage vulnerability management activities.
•CISSP or other Industry certification 


Requisition ID: 483649

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.


Nearest Major Market: Boston

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