Principal Engineer – TSMS Packaging

BioSpace; Pleasant Prairie (WI); On-site; USD 68,000 - 174,000; Full time

Benefits offered by this job

Company bonus

401(k) plan

Medical, dental, vision benefits

Job summary

Lilly Kenosha County (LKC) site seeks a Packaging Principal Engineer to provide technical oversight for packaging materials, equipment, and operations. This role leads tech transfer, process validation, and sustaining commercial support across a greenfield site and beyond.

As the site expert, you will ensure regulatory alignment, drive continuous improvement, and mentor TSMS engineers while coordinating with upstream suppliers and the global packaging network.

Qualifications

• Bachelor's degree or higher in engineering, science, or a related field.
• Engineering experience in plant, process, project delivery, maintenance, or related fields supporting packaging operations.
• Minimum of 5 years of experience in a manufacturing organization.
• Experience supporting cGMP manufacturing operations.
• Oral and written communication skills to communicate across all levels.

Responsibilities

• Provide technical oversight for packaging materials, equipment, and operations at the site.
• Lead tech transfer, qualification, and validation activities for packaging.
• Develop and implement technical agendas and mentor TSMS engineers.
• Support start-up activities and coordinate with upstream suppliers and the network.

Skills

Engineering experience

cGMP knowledge

Strong communication

Education

Bachelor's degree in Engineering

Tools

SAP

Veeva Vault

Electronic batch records

Microsoft Office

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Responsibilities

The TSMS Packaging Principal Engineer is a technical position that provides technical oversight and leadership for packaging materials, equipment, and operations at the Lilly Kenosha County (LKC) site. As LKC is a greenfield site, this role will be foundational in standing up the packaging technical program --- from equipment and packaging line design input, through tech transfer and process validation (PV), to sustaining commercial support. Upon the start of commercial production, the role's objectives shift to maintaining the validated state of applicable processes, monitoring metrics to ensure a state of control and capability, harmonizing control strategies across process teams, driving continuous improvement, and serving as an escalation point for day-to-day packaging operations issues. Primary objectives include the start-up and compliant manufacturing of LKC products, including implementation of the packaging process control and validation strategy. The Packaging Engineer is responsible for providing technical support for the processes, materials, systems, and equipment associated with packaging. The scope of the role includes packaging for products transferred to and/or launched at the LKC site. While this role is not expected to be the technical expert on all products and platforms, it is expected to be the site expert in the regulatory, internal, and other requirements governing packaging. A key part of this role is ensuring consistency in approach and process across the product lifecycle --- from tech transfer through regulatory submission and into routine manufacturing --- and in aligning LKC's technical approach with sister DAP sites as the network matures. The role also develops and implements a technical agenda and serves as a mentor within the TSMS team, engaging in upstream and external-to-site activities related to packaging.

Key Objectives/Deliverables

• Understand the scientific principles required for packaging combination drug products, including the interaction of chemistry, equipment, aseptic processes, and container closure systems.
• Serve as a technical SME during the design, build, and commissioning phases at a greenfield site, providing manufacturing science input into packaging line, equipment, and material design to support future tech transfer and validation.
• Own the technical agenda for the LKC Packaging TSMS program.
• Provide technical oversight for packaging materials, including serving as site lead for printed packaging materials and serialization as the program matures.
• Provide packaging technical support to operations with respect to materials, equipment, and processes.
• Lead technical evaluations and problem resolution, including troubleshooting and root cause analysis.
• Lead risk assessments of packaging operations and packaging material suppliers.
• Provide technical support for all start-up activities (e.g., tech transfer, equipment/process qualification, process validation) ahead of and through PV.
• Provide technical support for non-routine investigations (e.g., deviations, complaints), including consultation on quality and stability.
• Prepare, review, approve, and provide technical support for relevant technical documents, such as: change controls, regulatory submissions, deviation investigations, validation protocols and summary reports, processing records, procedures, PFDs, PFMEAs, VMPs, APRs, Process Monitoring, and specifications.
• Ensure an accurate instruction set (tickets & procedures) describes the process as performed and the control strategy for discrete manufacturing steps.
• Lead risk management activities pertaining to assigned products and processes.
• Develop, monitor, and appropriately react to statistically based metrics in real time to assess process variability and capability.
• Identify opportunities and lead TSMS technical projects to ensure a successful site start-up and improve process control, yield, product quality, and/or productivity; implement process changes and improvements through the technical agenda.
• Serve as a technical interface with upstream suppliers, equipment vendors, and the global packaging network, including sister-site DAP teams, to drive technical consistency across the network.
• Serve as a technical mentor for TSMS engineers, scientists, and other disciplines.
• Represent the LKC TSMS team for internal and external communications, including with suppliers.
• Provide audit and regulatory inspection (including PAI) support, as needed.
• Work within and lead cross-functional teams in a positive manner to implement TSMS objectives and deliver on business plan and quality objectives.
• Ensure a safe working environment through compliance with safety rules and by actively participating in safety-related activities, helping to establish a strong safety culture from site start-up.

Basic Qualifications

• Bachelor's degree or higher in engineering, science, or a related field.
• Engineering experience in plant, process, project delivery, maintenance, or related fields supporting packaging operations.
• Minimum of 5 years of experience in a manufacturing organization (or other related experience).
• Experience supporting cGMP manufacturing operations.
• Strong interpersonal and teamwork skills.
• Strong self-management and organizational skills, with the ability to operate with a high degree of autonomy in a start-up environment.
• Oral and written communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Additional Skills/Preferences

• MS in packaging engineering.
• Understanding of packaging specifications, qualification processes, product/package stability, and packaging components.
• Experience with vendor management, including selection and qualification.
• Familiarity with technology advances in packaging, including serialization.
• Technical transfer experience, including equipment qualification and process validation.
• Experience supporting or standing up a new site, line, or greenfield facility.
• Root cause investigation experieince
• Demonstrated successful leadership of cross-functional teams.
• Previous experience with deviation and change management systems.
• Proficiency with computer systems including Microsoft Office products, Veeva Vault, electronic batch records, and SAP.

Additional Information

• Role is Monday through Friday based. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.). Occasional extended hour and / or off-hour work may be required.
• Some travel may be required to other manufacturing sites and Lilly’s corporate office

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. For GMP purposes, the job description should be updated for significant changes. As always, you should consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $67,500 - $173,800. Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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