Lead Purification Process Engineer, GMP API

100 Eli Lilly and Company; United States; On-site; USD 66,000 - 172,000; Full time

Job summary

The Principal Process Engineer at Lilly leads technical assessment and support for production operations in API manufacturing for oligonucleotide, peptide, and bioconjugate purification, driving design, qualification, and delivery of purification equipment.

You will mentor junior engineers, conduct risk assessments, perform equipment walkdowns during commissioning, and ensure compliance with cGMP and Quality System requirements, collaborating across HSE, QA, Automation, Operations, and

Qualifications

• BS or MS in chemical engineering or related discipline and a minimum of 5 years of experience with a pharmaceutical, biotech, or CMO environment supporting the process engineering of drug substance active pharmaceutical ingredient (API) manufacturing or development.
• Authorized to work in the United States on a full-time basis.
• Lilly will not provide sponsorship for 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.
• Experience with GMP manufacturing environments and process engineering of API manufacturing or development.

Responsibilities

• Provide technical assessment and support for production operations in process knowledge, equipment support, and process optimization for API manufacturing.
• Mentor junior engineers and drive cross-functional technical projects.
• Drive progression of design, qualification supporting documentation, and delivery of purification equipment.
• Represent the process engineering team in Facility Acceptance Testing for assigned equipment.
• Perform equipment walkdowns during commissioning and qualification to identify issues and enable on-time facility delivery.
• Ensure records and technical notebooks are maintained and compliant with Quality System requirements.

Skills

Mentoring

Analytical skills

Problem-solving

Communication skills

Team collaboration

Data-driven decision making

Education

BS or MS in chemical engineering or related discipline

Tools

DeltaV

Rockwell

OSI-PI

Dynochem

Aspen

Electronic lab notebooks

Job description

The Principal Process Engineer at Lilly leads technical assessment and support for production operations in API manufacturing for oligonucleotide, peptide, and bioconjugate purification, driving design, qualification, and delivery of purification equipment.

You will mentor junior engineers, conduct risk assessments, perform equipment walkdowns during commissioning, and ensure compliance with cGMP and Quality System requirements, collaborating across HSE, QA, Automation, Operations, and