When you join us at Thermo Fisher Scientific, you'll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
How will you make an impact?
In this role you will manage a portfolio of internal projects, related to electronic systems, process improvements, input and assessment of equipment validation protocols, and quality reporting. You will provide on floor Quality support, attends RAPIDS and performs deviation investigations as needed. You will participate in Failure Mode and Effect Analysis (FMEAs) and process improvements determined from trending data.
What will you do?
- Manages multiple small-medium projects and/or improvement initiatives
- Leads risk analyses
- Assures continuous Quality improvement in plant related to trends from Quality systems
- Leads Quality initiatives, and provides Q support throughout the facility, quality assessments on process improvement activities such as Kaizens
- Works with management to resolve project issues and resource constraints within the team.
- Supports decision making on projects and future directions by trending deviations in Track Wise (TW)
- Prepares and reports on Quality metrics
- Supports qualification and validation activities for projects involving GxP relevant computer systems in conjunction with Functional Leads, Systems Administrators, Process and/or Systems Owners to incorporate appropriate elements of quality and compliance into the system life cycle.
- Participates in assessment of legacy/in-place computer systems software applications to ensure their validation documentation packages meet compliance standards, identify gaps and risk exposures. Partners with the Corporate Computer Systems Validation/Compliance organization to gain in-depth understanding of guidelines, requirements and general expectations related to Computer Systems Validation/Compliance most current best practices and latest published regulatory and industry guidance.
- Works closely with current Functional Leads, Systems Administrators, Process and/or Systems Owners to acquire knowledge of the existing systems so that the knowledge can be applied for assessment of development and execution of validation activities for computerized systems.
How will you get there?
- Bachelor's Degree in a Science related field
- 5 years' experience in a manufacturing environment
- GMP experience is an asset
- Equipment qualification experience is desired
- Project management experience
- Ability to travel up to 10%
- Strong critical thinking skills, creative problem solving and ability to work both independently and within a team environment
- Ability to multi-task, prioritize, and meet deadlines
- Strong interpersonal skills, organizational skills, and strong attention to detail needed
- Demonstrated proficiency with English language, both oral and written
- Proficiency with Microsoft Office Applications.
Equivalent combinations of education, training, and relevant work experience may be considered.
At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
Thermo Fisher Scientific is an equal opportunity employer and is committed to the principle of diversity and is particularly interested in receiving applications from a broad spectrum of people. Accommodations for job applicants with disabilities are available upon request.
Apply on company website