Process Engineer – Dry External Manufacturing

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.

Company Overview

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Indiana, Lilly makes life better – through medicines and information – for some of the world's most urgent medical needs. Founded over 145 years ago, the company has sustained a culture that values excellence, integrity, and respect for people. This has resulted in Lilly frequently being ranked as one of the best companies in the world at which to work. Lilly knows its business has prospered because of its employees – people with a talent for innovation and a passion for making a difference by finding treatments for the most stubborn diseases; people whose talent is matched by their generosity, and people with strong values and a determination to prevail, regardless of the challenges. Join our team – and make a difference in improving health for people all over the world!

Manufacturing and Quality Technical Hub Hyderabad

Lilly has made a strategic investment of more than $1B dollars to establish a Manufacturing and Quality technical hub in Hyderabad, India. This hub will oversee the significant investment in contract manufacturing and the technical services responsible for managing the scientific agenda for manufacturing and quality. The hub will be recruiting top talent in the areas of manufacturing operations, quality assurance, quality control, supply chain, technical services, and engineering to build a cutting-edge scientific organization supporting the exciting dry products external manufacturing portfolio of Lilly.

Job Description

Role Overview and Key Responsibilities:

The Dry Products Process Engineer provides technical leadership and support in conjunction with Dry Products External Manufacturing contract manufacturer personnel for the reliable supply and commercialization of medicines with safety first and quality always. The role develops and sustains process knowledge, provides process and equipment support, drives continuous improvement, and ensures HSE/PSM compliance at contract manufacturing sites.

Key Objectives/Deliverables:

Utilize past experiences with unit operation control to provide insight and feedback to members of the CM Joint Process Team (JPT).

Champion the application of statistical thinking and use of data to monitor process performance and make engineering decisions with CM members of the JPT.

Support and peer review root cause analysis around FUME and operational incidents.

Identify process knowledge gaps that impact equipment and process capability; develop or support the capture of key process knowledge.

Identify systemic issues affecting production and reliable supply from CMs; lead or participate in root cause analysis and countermeasure development.

Support development and technical analysis for ongoing continuous improvement activities; review and identify cost reduction opportunities.

Create methodology to ensure visibility of the ongoing state of qualification of key FUME systems at CMs.

Serve as liaison for Dry-EM and Global HSE on health, safety, and environmental (HSE) and process safety management (PSM) oversight at contract manufacturing sites.

Understand and follow all applicable Lilly policies and procedures with respect to interactions and oversight of Dry-EM contract manufacturing sites (FRAP, Red Book, contract manufacturing standards, engineering standards, and Quality policies).

Basic Requirements:

BE/BTech/M.E/M.Tech in Mechanical or Chemical Engineering, or any another engineering discipline

Relevant manufacturing experience in Dry Product manufacturing of Tablets/Capsules  of at least 8 years

Technical knowledge of Dry manufacturing equipment and unit operations.

Demonstrated ability to apply engineering principles to process understanding, problem solving, and process improvement.

Demonstrated ability to function in a team environment as a technical leader and as a member of teams.

Demonstrated ability to manage and prioritize competing priorities and to communicate verbally and in writing to various audiences.

Thorough understanding of cGMPs and drug product manufacturing.

Experience in Statistical Process Control (SPC) and Six Sigma or Lean Tools and principles.

Willingness to travel and appreciation for cultural diversity and inclusive leadership.

Additional Preferences:

Experience in typical unit operations for Dry Products Manufacturing (e.g., Spray Dry, Granulation, Tablet Press, Encapsulation, and Coating).

Successful application of root cause analysis and systematic problem solving.

Strong computer skills in a variety of software packages (e.g., Batch Plus, JMP, Visio, Aspen, Dynochem, OSI PI, MS Office Suite).

Ability to visualize an operation/process and reflect it in a model.

Good judgment, flexibility, and ability to work independently as well as in a team.

Education Requirements:

Bachelor of Engineering degree in Mechanical or Chemical science, or another engineering discipline with extensive manufacturing experience with 12+ years experience or MTech/Ph.D in chemical engineering with 5+ years of experience

Other Information:

Normal schedule is Monday–Friday, 8 hours/day; teleconferences may occur outside these hours due to CM time zones.

International travel may routinely be required to support process start-ups, troubleshooting, and commercial manufacturing (typically 15–25% annually).

Person-In-Plant (PIP) may be required for periods of time.

Tasks require entering manufacturing and laboratory areas; appropriate PPE required.

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. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly 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.

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