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Sr. Manufacturing Execution System Manager
2 months ago
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Location:
Role will sit remotely on the East Coast (US) only.
How will you make an impact?
The Computer System Quality Assurance Team provides quality oversight of business enterprise applications within the Pharmaceutical Services Group (PSG) of Thermo Fisher Scientific, ensuring compliance to regulations for computer system validation (CSV) and assurance with respect to data integrity, computer system lifecycle activities, change and deviation management. We support a global business network across multiple time zones, collaborating with global Quality, IT, and business groups to support multi-functional projects and continuous improvement initiatives. We share and implement standard methodologies within our assigned project scope, support regulatory audits, and assist with site deviations with global application impact. We appreciate and respect diversity and cultivate an inclusive environment.
What will you do?
- Collaborate in the optimization of the Corporate MES Validation strategy to standardize and harmonize the global CSV MES standards, templates and approved global documents that can be applied by the sites.
- Influence and collaborate with internal and external team members, build strong relationships in order to achieve goals.
- Implementation, integration and functionalities of manufacturing execution system.
- Collaborate with system owners and business process owners to meet business and regulatory requirements that are inclusive of system design, validation, implementation and lifecycle management.
- Evaluate and resolve quality and compliance issues for infrastructure and application.
- Drive operational excellence.
- Up to 25% domestic and/or international travel may be required.
How will you get here?
Education:
- Minimum required education: Bachelor's Degree, or higher, in Science, Engineering or QA/Regulatory related course of study.
Experience:
- 8+ years of direct pharmaceutical experience (QA, QC, or Regulatory Affairs).
- Computer System Validation (CSV) experience required.
- Prior experience/ proven grasp of MES solutions required.
- Prior people management/ leadership experience required.
- Must have a clear understanding of risk in computerized systems and be able to communicate actions, compliance gaps, and commitments to respective areas, including the senior Quality leadership.
Knowledge, Skills, Abilities:
- Knowledge of the latest on evolving regulatory requirements related to validation, computer systems, and data integrity requirements
- Strong decision-making capabilities, with the ability to look ahead and see how decisions in the present affect the future.
- Learn corporate and site processes to better collaborate and hold effective, balanced debates.
- Proficient in Microsoft Office Suite
- Appreciates and respects diversity and norms.
- Self-starter with strong leadership skills.
- Effective at multi-tasking and responding to shifting priorities.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one global team of 100,000 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.
Apply today
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.
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