Full-Time

Principal Process Engineer

Posted on 7/31/2025

Lilly USA

Lilly USA

10,001+ employees

Global pharmaceutical company developing medicines

Compensation Overview

$64.5k - $167.2k/yr

+ Bonus

Indianapolis, IN, USA + 1 more

More locations: United States

Hybrid

Category
Biology & Biotech (2)
,
Requirements
  • Bachelor's Degree in Engineering, Science or related field.
  • 5+ years' experience in pharmaceutical manufacturing or regulated industry.
  • In-depth knowledge of GMPs, risk management, and process/equipment commissioning and qualification practices.
Responsibilities
  • Demonstrate a strong ownership for the equipment and packaging area you support by being flexible, proactive and involved. Serve as a responsible engineer for site process lines by possessing a deep knowledge of equipment and unit operation design characteristics and capabilities on assembly and packaging lines.
  • Ensure the equipment is maintained in its validated state (AQM).
  • Approve the scope of qualifications and re-qualification monitoring activities.
  • Review and/or approve significant changes, maintenance, and other interventions for potential adverse impact on the safety or quality integrity of the equipment or process.
  • Provide equipment and processing support for production issue resolution and investigation with data analysis and first principles applications, ensuring reliable solutions, safe execution, and regulatory compliance.
  • Identify and drive improvement opportunities.
  • Support with complex sites investigation of key safety and production issues and events and work on the identification and implementation of CAPA plans to address such events and prevent recurrence.
  • Ensure adherence to current regulatory requirements, including cGMP standards, OSHA regulations, and environmental sustainability goals.
  • Support site inspection readiness and execution. This role has direct interaction with Regulatory Agencies during site inspections.
  • Develop local processes and procedures to enhance efficiency and effectiveness, utilizing lean tools for success.
  • Use first principles and theoretical knowledge to define scientific approaches to support technical improvements. Utilize in depth understanding of materials, process, and equipment to improve process robustness, reduce variability, and provide improvements in operational uptime and effectiveness.
  • Foster knowledge sharing and education within the team and with key internal and external partners to drive alignment, share best practices, technical principles and meet manufacturing goals.
  • Collaboratively integrate different disciplines such as quality, technical services, and operations on projects and process performance improvements.
  • Mentor and provide coaching to develop other technical resources on scientific approach, technology, as well as business approach and behaviors.
  • Create a safe and encouraging environment for colleagues to share ideas, contribute and thrive.
  • Willingness to openly share, to speak up and ensure others understand the risks when making business choices and decisions.
  • Lead by example in building and driving a culture of safety first and quality always within the organization.
  • Author, Review and/or approve GMP documentation including procedures, deviation investigations, technical reports, design reviews, change controls, validation protocols and summary reports, etc.
Desired Qualifications
  • Prior experience in packaging and/or dry/wet device assembling operations.
  • Experience with asset design, delivery, and start up preferred.
  • Safety equipment (PPE) and precautions required in the manufacturing plant environment.
  • Demonstrated, strong technical leadership and communication skills. Communicates effectively across disciplines and types of audiences (internal and external) to influence and/or drive common understanding and appropriate actions.
  • Strong interpersonal and presentation skills with the ability to collaborate effectively across diverse teams and stakeholders.
  • Ability to work well independently, as well as in teams. Provides partnership and collaboration across multiple disciplines.
  • Demonstrated, strong analytical and problem-solving abilities.
  • Variable travel of 0-50% plus could be expected based upon specific site and functional requirements.

Lilly is a global pharmaceutical company that discovers, develops, and sells prescription medicines to improve health outcomes. It grows its portfolio through extensive research and development, then manufactures and distributes drugs worldwide to healthcare providers who prescribe them to patients. Lilly’s products span diabetes, cancer, immunology, pain management, and other serious conditions, including diabetes treatments tirzepatide and dulaglutide. The company emphasizes safety, efficacy, and ethical practices, and protects its products from counterfeiting while partnering with organizations such as Team USA. Its approach relies on rigorous R&D, strong manufacturing, and a global distribution network to bring medicines to patients. Lilly’s goal is to help people live better lives by delivering reliable medical solutions through a global, ethical, and quality-focused operation.

Company Size

10,001+

Company Stage

IPO

Headquarters

Indianapolis, Indiana

Founded

1876

Simplify Jobs

Simplify's Take

What believers are saying

  • $4.5 billion LEAP investment opens genetic medicine facility for ALS therapies in 2027.
  • Profluent Bio partnership worth $2.25 billion accelerates AI-driven DNA editing for Alzheimer's.
  • Mounjaro added to China's National Reimbursement Drug List boosts international sales 95%.

What critics are saying

  • French ANSM fines Lilly €108,766 for Mounjaro ads, sparking global marketing restrictions.
  • FDA hepatic failure report on Foundayo triggers label changes slashing Zepbound's $4.16 billion sales.
  • Novo Nordisk's Wegovy dominates Europe with superior supply, capturing Mounjaro market share.

What makes Lilly USA unique

  • Mounjaro generated $8.7 billion in Q1 2026, surpassing Keytruda as world's best-selling drug.
  • Lilly commands 60.1% U.S. obesity and diabetes market share over Novo Nordisk's 39.4%.
  • Tirzepatide in Mounjaro and Zepbound drove 65% of Q1 2026 revenue.

Help us improve and share your feedback! Did you find this helpful?

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

401(k) Retirement Plan

401(k) Company Match

Paid Vacation

Flexible Work Hours

Wellness Program

Growth & Insights and Company News

Headcount

6 month growth

0%

1 year growth

-4%

2 year growth

-4%
The Lebanon Reporter
May 7th, 2026
Lilly invests additional $4.5B in LEAP district, opens first genetic medicine facility

Eli Lilly has announced an additional $4.5 billion investment in its Lebanon, Indiana facilities, bringing its total investment in the LEAP Innovation and Research district to $21 billion. The company opened its first Advanced Therapies site on Wednesday, marking the first operational facility in the 9,000-acre LEAP district. The new funding will support Lilly's Advanced Therapies laboratory and an active pharmaceutical ingredient facility expected to open in 2027. The Advanced Therapies site is Lilly's first dedicated genetic medicine manufacturing facility, focusing on molecular-level research for diseases including Alzheimer's, Parkinson's and ALS. Lilly is developing three facilities across 800 acres in LEAP, including a Medicine Foundry. The Advanced Therapies facility aims to accelerate delivery of breakthrough genetic medicines to patients.

AI Software Services
May 5th, 2026
Unlocking AI innovation in finance medicine and music.

Unlocking AI innovation in finance medicine and music. Published on May 05, 2026 GENETIC MEDICINE REVOLUTION: AI AND BIOTECH JOIN FORCES. In a groundbreaking partnership, Lilly and AI-driven Profluent Bio are teaming up in a deal worth up to $2.25 billion to develop advanced DNA editing tools. Their goal? To create precise treatments for genetic conditions that currently lack effective solutions, using innovative AI models to design enzymes that can target multiple mutations in the genome. This collaboration aims to unlock the "holy grail" of genetic medicine through kilobase-scale DNA editing. This matters because it could transform how AI Software Services treat genetic diseases, offering hope to millions who suffer from conditions deemed untreatable. The tools being developed are likely to be accessible, lowering barriers to entry in a field that has traditionally been expensive and exclusive. Imagine a startup that provides a platform for creators and developers to access these AI-driven genetic editing tools, enabling them to innovate and create personalized therapies. This could attract investors eager to support the next wave of medical breakthroughs!

The Economic Times
May 4th, 2026
French fines over anti-obesity adverts for Novo Nordisk, Eli Lilly.

French fines over anti-obesity adverts for Novo Nordisk, Eli Lilly. The ANSM fined Novo Nordisk 783,838 euros regarding adverts for Wegovy and also fined Lilly France 108,766 euros for a campaign promoting its anti-obesity drug Mounjaro, seeing the adverts as "likely to constitute indirect promotion of medicines subject to mandatory medical prescription." * Updated On May 4, 2026 at 05:54 PM IST Paris: France's medicine safety agency ANSM said Monday it had imposed fines on pharmaceutical firms Novo Nordisk and Eli Lilly over their advertising campaigns on obesity. The agency fined on Novo Nordisk France 1.78 million euros ($2.08 million) - a million relating to adverts promoting its Saxenda drug and 783,838 euros regarding adverts for Wegovy weight management medication for treating obesity. The ANSM also fined Lilly France 108,766 euros for a campaign promoting its anti-obesity drug Mounjaro, seeing the adverts as "likely to constitute indirect promotion of medicines subject to mandatory medical prescription." French laws prohibit any advertising to the general public of the treatments. The national medicines regulator said that the fines aimed to "prevent any communication likely to promote the use of drug treatment as the principal response to obesity, to encourage the public to request this treatment from a healthcare professional or seek to obtain it themselves." Event. * Fri, 24 Jul 2026 * Le Meridien, Hyderabad The ANSM said the advertising campaigns were "likely to mislead the public in a context marked by extensive media coverage" as well as what it termed growing inappropriate use of medications which activate certain hormones in order notably to reduce appetite,and aid weight loss. In a statement to AFP, Novo Nordisk France said it "strongly contests" the ANSM's finding, adding it is "exploring all possible appeal avenues against this decision". Lilly France said it noted ANSM's decision, while stating it believes its awareness campaign entitled "Obesity is a sick person's problem" from a year ago was "in line with the framework applicable to communications relating to human health". According to a French study published in 2024, around 18 percent of the French population - equivalent to some ten million people - are obese.

NBC News
Apr 14th, 2026
FDA requests more safety data from Lilly on weight loss pill Foundayo

The FDA is requesting additional safety data from Eli Lilly for its weight loss pill Foundayo, including information on potential heart and liver problems, according to the approval letter published Tuesday. The agency wants more data on risks including heart attacks, strokes, drug-induced liver injuries and delayed stomach emptying. Foundayo, approved this month under a fast-track pilot programme, is the second oral GLP-1 to reach market after Novo Nordisk's Wegovy pill. The FDA is also asking Lilly to collect thyroid cancer risk data for at least 15 years. The requests are considered routine for newly approved drugs, particularly for orforglipron, Foundayo's active ingredient, which has less safety data than older GLP-1s. Lilly must also establish registries tracking children with obesity and pregnancy outcomes.

PR Newswire
Apr 14th, 2026
Vasa Therapeutics partners with Lilly TuneLab to accelerate AI-driven CAMKII inhibitor development

Vasa Therapeutics, a clinical-stage biopharmaceutical company, has partnered with Eli Lilly to use Lilly TuneLab, an AI-enabled drug discovery platform that provides access to models trained on Lilly's proprietary research data. Vasa will use the platform to accelerate development of its CAMKII delta inhibitor, which is planned for Phase 1 clinical trials in 2027. The company's VS-041 is currently in a proof-of-mechanism trial for heart failure, whilst VS-214 is on track for first-in-human trials in 2026. The platform uses federated learning, allowing companies to access Lilly's AI models whilst maintaining data privacy. Vasa will contribute its own experimental datasets to support the platform's improvement. The company focuses on developing therapies for cardiovascular, neuromuscular and age-related disorders.

INACTIVE