Senior Computer Systems Validation Compliance Specialist

Job Description : Job Title

Job Title

Senior Computer Systems Validation Compliance Specialist

Collaborate with Innovative 3Mers Around the World

Choosing where to start and grow your career has a major impact on your professional and personal life, so it’s equally important you know that the company that you choose to work at, and its leaders, will support and guide you.

With a diversity of people, global locations, technologies and products, 3M is a place where you can collaborate with other curious, creative 3Mers.

This position provides an opportunity to transition from other private, public, government or military experience to a 3M career.

The Impact You’ll Make in this Role

As a Senior Computer Systems Validation Compliance Specialist , you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world.

Here, you will make an impact by :

• Plan and execute control assessments, across applications, or within a single application.
• Review validation documentation to ensure risk level is adequately reflected in the level of documentation detail
• Ensure compliance requirements are documented, complete, and correct
• Ensure testing covers and challenges requirements, and is completed according to IT standards
• Monitor change management processes to ensure compliance with global and standard operating procedures
• Be responsible for ensuring that confidential and sensitive information is protected and monitored accordingly
• Provide support for internal and external audits
• Ability to work in a collaborative manner with technical and non-technical personnel
• Must possess a high degree of integrity and trust, along with the ability to work independently
• Requires good interpersonal skills, ability to function in a fast paced and short-deadline environment
• Ability to manage multiple issues and projects at the same time
• Coach / educate Validation Leads on audit findings

Your Skills and Expertise

To set you up for success in this role from day one, 3M requires (at a minimum) the following qualifications :

• Possess a two-year degree or diploma (completed and verified prior to start) from an accredited institution & two (2) combined years of IT systems software and / or application software project experience & six (6) years of experience working in an environment restricted by regulation or contract in a private, public, government or military environment.
• Bachelor's degree or higher (completed and verified prior to start) from an accredited institution & two (2) combined years of IT systems software and / or application software project experience & four (4) years of experience working in an environment restricted by regulation or contract in a private, public, government or military environment.

Additional qualifications that could help you succeed even further in this role include :

• Auditor certification
• Working knowledge of cGMP guidelines, FDA 21 CFR Part 11 regulations, and other international regulatory requirements
• Sound industry knowledge, project proficiency, and autonomy expected
• Experience leading teams
• Experience working in a highly regulated environment
• Experience with full software development lifecycle (SDLC)
• Experience working in an IT Risk Management organization
• Strong analytical skills
• Working knowledge of industry standard control frameworks
• Demonstrates initiative; ability to undertake additional responsibilities and respond to situations as they arise with little or no supervision

Work Location :

Work Your Way Eligible (Employee choice to work remote, on site, or hybrid)

Travel : n / a

Relocation Assistance : Is not authorized.

Supporting Your Well-being

3M offers many programs to help you live your best life both physically and financially. To ensure competitive pay and benefits, 3M regularly benchmarks with other companies that are comparable in size and scope.