Process Engineering Manager, Manufacturing
Elanco
August 16, 2026
On-site
Elwood, KS
Operations
Your Role: Process Engineering Manager, Manufacturing
Supports the design, operation, control, and optimization of manufacturing processes and assets at the Elwood, Kansas monoclonal antibody (mAb) facility. Provides technical expertise in process performance and equipment, including data analysis, troubleshooting, technology transfer, and continuous improvement. Provides leadership to front-line process engineers.
Responsibilities:
- Support capital projects: design, development, commissioning, qualification, and validation; scope definition, user requirements, equipment selection, and construction oversight.
- Develop/analyze process designs (mass/energy balances); contribute to facility, utility, and equipment sizing; serve as SME on process/equipment.
- Author/review/maintain technical documentation (URS, P&IDs, PFDs, safety assessments, commissioning/qualification).
- Provide manufacturing troubleshooting; document/investigate issues; resolve via root cause analysis and corrective/preventive actions.
- Maintain validated state and ensure cGMP and regulatory/company compliance; support change management.
- Use data-driven analysis to improve process performance and capacity (efficiency, reliability, cost-effectiveness).
- Assess process change impact on quality, safety, regulatory compliance, and environmental requirements; support process safety (HAZOP, risk mitigation).
- Build/develop the Process Engineering function (coaching, standard work, KPIs).
- Promote safety culture; adhere to HSE and quality standards (“Safety First and Quality Always”).
Minimum Qualifications:
- Bachelor’s degree (or equivalent) in an engineering discipline.
- 5+ years in pharmaceutical/biotech or related industry; analytical/problem-solving skills; working knowledge of cGMP or regulated environment; cross-functional collaboration; strong communication/organization/computer skills; independent work.
Preferred Qualifications:
- 7+ years industry experience with leadership/supervisory experience; knowledge of mAb/recombinant protein manufacturing.
- Biologics experience (cell culture; purification: chromatography/TFF; viral inactivation; sterilization).
- Experience with commissioning/qualification/validation, technology transfer, commercialization; capital project design/execution.
- Familiarity with SAP, ERP, AutoCAD, Veeva Vault; RCI, FMEA, QRM.
- Working knowledge of USDA and/or EMA regulations for veterinary biologics.
Benefits:
- Multiple relocation packages; 8-week parental leave; annual bonus offering; flexible work arrangements.
Location/Work: Elwood, Kansas. On-site, full-time (day shift; occasional off-hours support). Minimal travel.
Supports the design, operation, control, and optimization of manufacturing processes and assets at the Elwood, Kansas monoclonal antibody (mAb) facility. Provides technical expertise in process performance and equipment, including data analysis, troubleshooting, technology transfer, and continuous improvement. Provides leadership to front-line process engineers.
Responsibilities:
- Support capital projects: design, development, commissioning, qualification, and validation; scope definition, user requirements, equipment selection, and construction oversight.
- Develop/analyze process designs (mass/energy balances); contribute to facility, utility, and equipment sizing; serve as SME on process/equipment.
- Author/review/maintain technical documentation (URS, P&IDs, PFDs, safety assessments, commissioning/qualification).
- Provide manufacturing troubleshooting; document/investigate issues; resolve via root cause analysis and corrective/preventive actions.
- Maintain validated state and ensure cGMP and regulatory/company compliance; support change management.
- Use data-driven analysis to improve process performance and capacity (efficiency, reliability, cost-effectiveness).
- Assess process change impact on quality, safety, regulatory compliance, and environmental requirements; support process safety (HAZOP, risk mitigation).
- Build/develop the Process Engineering function (coaching, standard work, KPIs).
- Promote safety culture; adhere to HSE and quality standards (“Safety First and Quality Always”).
Minimum Qualifications:
- Bachelor’s degree (or equivalent) in an engineering discipline.
- 5+ years in pharmaceutical/biotech or related industry; analytical/problem-solving skills; working knowledge of cGMP or regulated environment; cross-functional collaboration; strong communication/organization/computer skills; independent work.
Preferred Qualifications:
- 7+ years industry experience with leadership/supervisory experience; knowledge of mAb/recombinant protein manufacturing.
- Biologics experience (cell culture; purification: chromatography/TFF; viral inactivation; sterilization).
- Experience with commissioning/qualification/validation, technology transfer, commercialization; capital project design/execution.
- Familiarity with SAP, ERP, AutoCAD, Veeva Vault; RCI, FMEA, QRM.
- Working knowledge of USDA and/or EMA regulations for veterinary biologics.
Benefits:
- Multiple relocation packages; 8-week parental leave; annual bonus offering; flexible work arrangements.
Location/Work: Elwood, Kansas. On-site, full-time (day shift; occasional off-hours support). Minimal travel.