Process Engineering Manager, Manufacturing

Elanco•Elwood, KS

17h•Onsite

About The Position

The Process Engineering Manager, Manufacturing supports the design, operation, control, and optimization of manufacturing processes and assets at the Elwood, Kansas monoclonal antibody (mAb) facility. This role develops deep technical expertise in process performance and equipment, contributing to data analysis, troubleshooting, technology transfer, and continuous improvement initiatives. The Process Engineering Manager plays a key role in both capital project delivery and day-to-day manufacturing support. In addition, this position provides leadership to front-line process engineers and helps establish business processes aligned with Elanco operational standards.

Requirements

Bachelor’s degree (or equivalent) in an engineering discipline.
5+ years of experience in pharmaceutical, biotechnology, or a related industry.
Strong analytical and problem-solving skills, with working knowledge of cGMP or experience in a regulated environment.
Demonstrated ability to work effectively in cross-functional teams.
Strong communication, organizational, and computer skills, with the ability to manage priorities and work independently.
Qualified candidates must be legally authorized to be employed in the United States.

Nice To Haves

7+ years of industry experience with prior leadership or supervisory experience.
Understanding of monoclonal antibody or recombinant protein manufacturing processes.
Experience in biologics manufacturing, including cell culture, purification (chromatography, tangential flow filtration), viral inactivation, and sterilization processes.
Experience with commissioning, qualification, validation, technology transfer, and new product commercialization.
Background in capital project design and execution.
Familiarity with SAP, ERP systems, AutoCAD, and Veeva Vault.
Experience applying RCI, FMEA, and QRM tools.
Working knowledge of USDA and/or EMA regulations for veterinary biologics.

Responsibilities

Provide process engineering support for capital projects, including participation in design, development, commissioning, qualification, and validation activities.
Support scope definition, user requirements, equipment selection, and construction oversight to ensure successful project delivery.
Develop and analyze process designs, including mass and energy balances, and contribute to facility, utility, and equipment sizing.
Serve as a subject matter expert on process and equipment within cross-functional teams.
Author, review, and maintain technical documentation such as user requirement specifications (URS), P&IDs, PFDs, safety assessments, and commissioning and qualification documents.
Provide technical support for manufacturing operations, including troubleshooting process and equipment issues.
Ensure issues are properly documented, investigated, and resolved through root cause analysis and corrective and preventive actions.
Monitor and maintain processes and equipment in a validated state, ensuring compliance with cGMP requirements and all regulatory and company standards.
Support change management activities to ensure modifications do not impact the qualified state.
Use data-driven analysis to evaluate process performance and capacity, identifying and implementing improvements that enhance efficiency, reliability, and cost-effectiveness.
Assess the impact of process changes on product quality, safety, regulatory compliance, and environmental requirements.
Lead or support process safety activities, including HAZOP reviews and risk mitigation efforts.
Build and support the Process Engineering function by coaching and developing team members, establishing standard work, and defining key performance indicators to support manufacturing operations.
Promote a strong safety culture and ensure adherence to all health, safety, environmental, and quality standards, exemplifying a “Safety First and Quality Always” mindset.