Jobs for People with MS: National MS Society

Job Description

When you join us at Thermo Fisher Scientific, you’ll do ambitious work, and be part of a team that values performance, quality, and innovation. Within this successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $24 billion and the largest investment in R&D in the industry, we provide our people the resources and challenges to deliver significant contributions to the world!

How will you make an impact?

As a member of the PSG IT Core Services Team delivering solutions & support in partnership with local and global functions, we will provide operational compliance and technical support to the site driving efficient and compliant technology solutions.

What will you do?

• Key contact to ensure operational compliance of IT

• Collaborate with global teams to align, develop and implement IT processes, policies, procedures and documentation to meet industry standards, regulatory, business and quality requirements.

• Support IT functions identifying issues/risks, performing gap analysis, plan elaboration, definition, and monitoring of the corrective actions.

• IT point of contact (POC) supporting project activities conducted by the CSV team and for new manufacturing lines, digital performance management, Industry 4.0 (Rockwell Factory Talk).

• Ensure IT systems are maintained in GxP validated state for intended purpose.

• Drive the execution of smaller projects within scope, budget, and schedule by developing and completing project documentation to support the business requirement, technology need and regulations; Includes short and long-term manufacturing and automation project solutions. ​​

• Support site audit readiness and regulatory inspections, and client audits.

• Support creating and managing deviations, CAPAs and Change Controls.

• Maintains and performs periodic user reviews of main IT systems, updates, and refresh of IT operating procedures in collaboration with IT technical / application group, CSV, and quality team.

• Ensures the documentation provided by suppliers aligns with internal quality standards.

• Guide the periodic discussion on IT internal metrics sharing and Key Performance Indicator monitoring.

• Actively participate, seek opportunities, promote, and sustain PPI (Practical Process Improvement).

• Stay updated with industry trends, standards, and regulatory changes.

How will you get here?

Education and Experience:

• Bachelor’s degree in computer science or equivalent desireable.

• 3+ years of relevant, IT related work experience.

• Previous experience working in an IT compliance role.

• Experience working onsite in a customer facing and providing technical support.

• Experience working with EDMS and QMS systems writing changes, deviations, CAPAs.

• Experience writing test plans, designs, business processes, requirements, technical specifications.

• Experience in working with IT colleagues across various geographies and disciplines.

Knowledge, Skills, Abilities

• Working knowledge of IT Controls, GAMP5, GxP regulations, CSV, SDLC, Data Integrity, Part 11, Annex11, and relevant standards

• Strong analytical, prioritization, problem-solving, time management and organization skills

• Excellent written, verbal communication and interpersonal skills to effectively collaborate with multi-functional global/local teams and end-users.

• Ability to manage customer and supplier management relationship.

• Proven flexibility to balance and prioritize numerous tasks.

• Drive and desire to learn and grow both technical and functional skills.

• Participate in industry / functional area groups / forums and integrate / implement new lessons learned.

• ITIL Foundations Certification a plus

Our 4i Values:

As one team of 125,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need! #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.