Senior / Principal Process Engineer - API

The position of Senior / Principal Process Engineer - APIu00A0reports to the Director - Engineering API EM and provides technical leadership and expertise in conjunction with API EM contract manufacturer personnel in the reliable supply and commercialization of medicines with safety first and quality always by : u00A0

Developing and sustaining process knowledge in order to ensure the execution of the the appropriate product, process, and operational control strategy at a number of Contract Manufacturers (CMs).

Direct and Indirect interaction with CM personnel to ensure reliable supply via the CM execution of the operational control strategy.

FUME assessment to ensure an understanding of risk presented to the operational control strategy.

Participation with internal or CM resources in the equipment specification, procurement, and IQ / OQ / PQ.

Participation with internal and CM resources to assess the HSE and PSM elements of the CM that impact Lilly products.

Engaged with internal and external resources in developing capabilities with new or evolving technologies that may impact delivery of internal or external portfolio assets.

Adherence to the expectations of the Lilly Red Book when carrying out interactions with API EMu2019s CMs.

Key Objectives / Deliverables :

Coach and Mentor Process Team Members

Utilize past experiences with unit operation control to provide insight and feedback to members of the Lilly / 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.

Peer review documentation of learning points, technical studies, and incident investigations.

Develop and Sustain Process Knowledge

Identify process knowledge gaps that impact equipment and process capability.

Develop or support the capture of key process knowledge (examples include material and energy balances, kinetics, chemistry, process modeling, and equipment design basis).

Enable the development and maintenance of process knowledge. infrastructure such as key models, report history, lab models, and literature.

Utilize optimization resources and tools for process analysis and process improvement studies.

Review and track key process engineering metrics.

Provide Process & Equipment Support

Identify systemic issues affecting production and reliable supply from CMs

Lead or participate in root cause analysis and countermeasure development and implementation for major safety, quality, or throughput incident investigations.u00A0 Perform reviews of incident documentation for technical accuracy.

Review and approve documentation and engineering decisions.

Practice vs procedure walk throughs at the CM sites

Periodic housekeeping / fit & finish walk-throughs with area management.

Process Optimization & Continuous Improvement

Support development and technical analysis for on-going continuous improvement activities.

Review and identify cost reduction opportunities, as well as process capacities and bottlenecks.

Assist in prioritization of opportunities with respect to overall business objectives.

Work with the CMs to ensure the application of statistical thinking and methods to understand process variability and capability.

Perform and promote optimization of unit operation cycle time, loading, and yield performance.

Engage with late phase development and Engineering Technical Center resources to stay contemporary with key engineering disciplines and developing portfolio platforms (e.g. continuous manufacturing operations).

Equipment Capability and Asset Management

Review equipment and process system user requirements and qualification plans to ensure that the equipment and systems are appropriate for the intended purpose.

Act as customer representative for review of Contact Manufacturer (CM) requests for capital projects targeted at both short and long term needs.

Oversight of HSE and PSM

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

Leverage internal Lilly experts in HSE and PSM to ensure appropriate risk reduction at CMs.

Participate in Lilly HSE and PSM audits of contract manufacturing sites as applicable.

Maintain key HSE and PSM metrics for review within API EM.u00A0

Adherence to Business, Quality, and Financial Systems

Understand and follow all applicable Lilly policies and procedures with respect to interactions and oversight of API contract manufacturing sites.u00A0 These include, but are not limited to : u00A0 Financial Responsibility and Reporting (FRAP) Lilly Red Book Lilly contract manufacturing standards Lilly engineering standards, and Lilly Quality policies and best practices.

Basic Requirements :

10 years of work experience in a GMP manufacturing / process engineering related role

Deep technical knowledge of API / Drug Substance manufacturing equipment and unit operations.

Demonstrated ability to apply fundamental chemical 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 appropriately communicate verbally and in writing to various audiences.

Additional Preferences :

Experience in typical unit operations for Small Molecule API manufacturing or Peptide Synthesis / Purification manufacturing.

Develop and implement innovative approaches to problems

Process Hazard Analysis experience

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).

Visualize an operation / process and reflect it in a model.

Education Requirements :

Bachelor of Science degree in Chemical Engineering, or another engineering discipline with extensive GMP chemical manufacturing experience.

Other Information :

The normal schedule for this position is Monday-Friday, 8 hours / day. u00A0However, teleconferences may routinely occur outside of these hours due to the time zones of contract manufacturers.u00A0 International travel may be required to support process start-ups, troubleshooting, and commercial manufacturing.u00A0

Must complete assigned training curriculum.

No certifications required.

Tasks require entering manufacturing and laboratory areas and will require wearing appropriate PPE.

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 () 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.

Lillyu00A0does 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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Skills Required

Aspen, Root Cause Analysis, Visio, Jmp, Ms Office Suite, Osi Pi, Process Hazard Analysis