Thermo Fisher Scientific Engineer III - Upstream Production in Saint Louis, Missouri
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com .
When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals
How will you make an impact?
Operate cross functionally and collaborate with peers both within and outside of department to drive resolution of Operational technical challenges.
Act as technical SME for the Upstream Operations Team on all processes and provide guidance input on process requirements, specifications, and changes
Assist in technical and quality aspects of the Upstream Operations team including, but not limited to projects, audits, compliance, investigations, and events
Drive and support continuous improvement of Upstream processes and documentation as needed, including but not limited to Change Controls, CAPAs, SOPs, MBRs, Process Equipment, and Job Aids
Serve as an operations representative on departmental and site teams to improve and challenge processes, solve problems, initiate improvements, establish procedures, transfer new products or technologies, execute projects, etc.
Support the maturing of area systems on an annual basis
Be a resource/point of contact for other departments in relation to the needs of Upstream Operations
Collaborate cross-functionally to ensure the success of the processes and programs as needed
Partner with other areas to ensure good quality and cGMP practices with process changes
Live the Thermo Fisher Scientific 4Is values every day. Be proactive.
How will you get here? *
Bachelor's degree required*
5+ years of industry experience, preferably in a cGMP environment
5+ years of experience with key responsibilities required of the role including continuous improvement support of processes and related documentation and technical support.
Knowledge, Skills, Abilities
Understanding technical requirements associated with Downstream processes and the biopharma production environment
Excellent understanding of cGMP and other regulatory requirements in the operation of cleanrooms
Understanding of cGMP quality systems (e.g. change control, deviations, investigations, risk assessments, driving GDP within all documentation and records).
Ability to work both independently and in a team environment.
Ability to self-motivate, prioritize work and time.
Mechanical and technical ability/aptitude
Organized, efficient, and results oriented
Ability to follow-up and drive on commitments and detail oriented.
Expert in oral and written communication (verbal and written in English), as well as social skills.
Computer literate with Microsoft Office tools, including report writing and graphing.
Quality and/or Financial software (SAP, NextDocs, SuccessFactors, etc) skills a plus.
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. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.