Primary Loop Process Engineer
Elanco
1 month ago
On-site
Elwood, KS
Operations
Process Engineer (Day Shift)
Responsibilities:
- Provide technical and on-floor support for process and equipment by troubleshooting issues, assisting manufacturing teams, documenting problems in the quality management system, performing root cause analysis, and implementing corrective and preventive actions.
- Ensure equipment qualification and compliance with cGMP standards, company policies, and regulatory requirements; oversee interventions, maintenance, and changes with documentation through formal change control.
- Drive performance and process optimization through data analysis to monitor equipment/process performance, assess capacity, and identify continuous improvement opportunities.
- Lead and support the full lifecycle of capital projects (design, development, execution, commissioning, qualification, validation), including scope, design alternatives, equipment selection, user requirements, construction oversight, and process validation support.
- Develop and manage technical documentation and risk mitigation (user requirements, P&IDs, safety/environmental assessments, qualification protocols) and collaborate cross-functionally to identify risks and support value engineering.
Minimum qualifications:
- Bachelor’s degree in Chemical, Biological, or related engineering discipline.
- Experience in pharmaceutical, biotechnology, or a related/relevant industry.
- Knowledge of cGMP and/or experience in a regulated environment; success working in cross-functional teams.
Preferred qualifications:
- 2+ years of relevant industry experience.
- Experience with capital project design/development/execution.
- Understanding of monoclonal antibody/recombinant protein manufacturing processes.
- Experience with SAP EAM, ERP, AutoCAD, Veeva Vault, AVEVA PI, Seeq, Meridian.
- Understanding and application of RCI, FMEA, and QRM tools.
- Working knowledge of USDA and/or EU GMP regulations for veterinary biologics.
Benefits:
- Relocation packages; two-week shutdowns (mid-summer and year-end) in addition to PTO; 8-week parental leave; 9 Employee Resource Groups; annual bonus; up to 6% 401K matching.
Additional information:
- Location: Elwood, KS.
- Salaried day shift; weekend work required on rotation for process support.
Responsibilities:
- Provide technical and on-floor support for process and equipment by troubleshooting issues, assisting manufacturing teams, documenting problems in the quality management system, performing root cause analysis, and implementing corrective and preventive actions.
- Ensure equipment qualification and compliance with cGMP standards, company policies, and regulatory requirements; oversee interventions, maintenance, and changes with documentation through formal change control.
- Drive performance and process optimization through data analysis to monitor equipment/process performance, assess capacity, and identify continuous improvement opportunities.
- Lead and support the full lifecycle of capital projects (design, development, execution, commissioning, qualification, validation), including scope, design alternatives, equipment selection, user requirements, construction oversight, and process validation support.
- Develop and manage technical documentation and risk mitigation (user requirements, P&IDs, safety/environmental assessments, qualification protocols) and collaborate cross-functionally to identify risks and support value engineering.
Minimum qualifications:
- Bachelor’s degree in Chemical, Biological, or related engineering discipline.
- Experience in pharmaceutical, biotechnology, or a related/relevant industry.
- Knowledge of cGMP and/or experience in a regulated environment; success working in cross-functional teams.
Preferred qualifications:
- 2+ years of relevant industry experience.
- Experience with capital project design/development/execution.
- Understanding of monoclonal antibody/recombinant protein manufacturing processes.
- Experience with SAP EAM, ERP, AutoCAD, Veeva Vault, AVEVA PI, Seeq, Meridian.
- Understanding and application of RCI, FMEA, and QRM tools.
- Working knowledge of USDA and/or EU GMP regulations for veterinary biologics.
Benefits:
- Relocation packages; two-week shutdowns (mid-summer and year-end) in addition to PTO; 8-week parental leave; 9 Employee Resource Groups; annual bonus; up to 6% 401K matching.
Additional information:
- Location: Elwood, KS.
- Salaried day shift; weekend work required on rotation for process support.