Process Engineer

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 commercialisation 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.

Responsibilities:

Utilise 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).

Requirements:

Bachelor of Engineering degree in mechanical or chemical science or another engineering discipline with extensive manufacturing experience and 12+ years' experience or M. Tech. /Ph. D. in chemical engineering with 5+ years of experience.

BE/BTech/ME/MTech in mechanical or chemical engineering or any other 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 prioritise 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 drying, granulation, tablet pressing, 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, and MS Office Suite).

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

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

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 is required.