Process Engineering Manager, Manufacturing

Your 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.
• What You Need to Succeed (minimum qualifications):
• Education: Bachelor’s degree (or equivalent) in an engineering discipline.
• Experience: 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.
• What will give you a competitive edge (preferred qualifications):
• 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.
• Additional Information:
• Location: Elwood, Kansas
• This is an on-site, full-time position. Day shift role with occasional off-hours support as needed. Minimal travel requirements (<5%).
• Qualified candidates must be legally authorized to be employed in the United States.
• Don’t meet every single requirement?
• Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco, we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!
• Elanco Benefits and Perks:
• We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
• Multiple relocation packages
• 8-week parental leave
• 9 Employee Resource Groups
• Annual bonus offering
• Flexible work arrangements
• Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
• Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‐related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.