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.
R&D SDLC CSV Information technology (IT) data-integrity itil