When you are 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.
Location/Division Specific Information
The Thermo Fisher Bioproduction division in Detroit, Michigan is seeking a Process Engineer to join our process engineering team. This is a full time, salaried position. The Process Engineer will combine a strong technical background (biologics), problem solving, process knowledge, root cause analysis and project management skills to lead the implementation of new processes and improvement projects, drive problem resolution and support the validation of process changes in a cGMP biological process. This position will work closely with other engineers, Manufacturing and Quality department colleagues to meet production goals by implementing and optimizing manufacturing processes.
How will you make an impact?
The Process Engineer will make an impact on the organization by standardizing production processes and procedures. (S)he will conduct root cause analysis on process and product deviations and implement robust corrective and preventive actions. They will work closely with the quality organization to maintain and improve cGMP compliance.
What will you do?
Utilize Six Sigma and problem-solving tools gathering data to support root cause analysis completion.
Lead major product related Deviations, CAPAs, and process Change Control activities.
Lead the investigation and implementation of new manufacturing processes and systems.
Define requirements for new manufacturing processes, process improvements, and cost savings projects including project scope, timelines, resourcing and budget.
Standardize processes on the production floor.
Be a technical leader and support safety, quality, and productivity improvement goals.
Support execution of validation / process change protocols according to cGMP.
Provide hands on investigation of manufacturing issues and determine/implement appropriate resolution.
Provide hands on training and demonstration to manufacturing associates.
Perform studies / research / experimentation relating to material/process standardization and flow to increase overall operational efficiency and effectiveness.
Collect, record, analyze, and report data to wide audiences in a manner consistent with cGMP and ISO guidelines.
Occasional support will be required on afternoons, nights and weekends.
How will you get here?
Minimum of BS in Chemical, Biochemical, Metabolic, Biological Sciences / Engineering, Analytical Chemistry Microbiology. PhD in Chemical / Biochemical Engineering desired.
Minimum required education: Bachelor degree and high school diploma/GED
Protein Digestion, biochemical, biological systems, biotechnology experience is strongly preferred.
HPLC, CSTR, Filtration, pumping / piping systems, FTIR, Analytical lab experience a plus
Root Cause Analysis, Statistical analysis.
Pharma / Biologic (cGMP / ISO) manufacturing experience highly preferred.
5+ year’s process engineering experience in a cGMP environment preferred.
Project Management / Project Leadership experience.
Knowledge, Skills, Abilities
Strong written and verbal communication skills.
cGMP experience in a FDA regulated industry
Microsoft Office proficiency.
Six Sigma Certification desired.
JMP / Minitab experience desired
Leadership at all levels
Strong people skills
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