Senior Process Development Specialist
1 week ago
We are seeking a seasoned Process Engineering professional to drive technical excellence and leadership in the development and commercialization of medicines.
About the Role:
- Provide technical oversight and expertise to ensure the successful execution of process control strategies at contract manufacturers.
- Foster collaborative relationships with contract manufacturer personnel to guarantee reliable supply through effective operational control.
- Conduct FUME assessments to identify risks impacting operational control strategies.
- Participate in equipment specification, procurement, and qualification activities with internal and contract manufacturer resources.
- Evaluate health, safety, and environmental (HSE) and process safety management (PSM) elements at contract manufacturers affecting Lilly products.
Key Responsibilities:
- Serve as a coach and mentor to Process Team Members:
- Utilize past experiences with unit operation control to provide guidance and feedback to team members.
- Promote the application of statistical thinking and data-driven decision-making with team members.
- Support and review root cause analysis for FUME and operational incidents.
- Peer-review documentation of learning points, technical studies, and incident investigations.
- Develop and sustain process knowledge:
- Identify knowledge gaps affecting equipment and process capability.
- Develop or support the capture of key process knowledge, including material and energy balances, kinetics, chemistry, process modeling, and equipment design basis.
- Enable the development and maintenance of process knowledge infrastructure, such as models, report history, lab models, and literature.
- Apply optimization resources and tools for process analysis and improvement studies.
- Review and track key process engineering metrics.
- Provide process and equipment support:
- Identify systemic issues impacting production and reliable supply from contract manufacturers.
- Lead or participate in root cause analysis and countermeasure development for major safety, quality, or throughput incident investigations.
- Review and approve documentation and engineering decisions.
Process Optimization & Continuous Improvement:
- Support development and technical analysis for ongoing continuous improvement initiatives.
- Review and identify cost-saving opportunities and process bottlenecks.
- Assist in prioritizing opportunities aligned with business objectives.
- Collaborate with contract manufacturers to apply statistical thinking and methods to understand process variability and capability.
- Optimize unit operation cycle time, loading, and yield performance.
Equipment Capability and Asset Management:
- Establish a methodology to ensure visibility of FUME system qualification status at contract manufacturers.
- Review equipment and process system user requirements and qualification plans to ensure suitability for intended purposes.
- Serve as customer representative for reviewing contract manufacturer capital project requests.
Oversight of HSE and PSM:
- Act as liaison between API EM and global HSE on HSE and PSM oversight at relevant contract manufacturing sites.
- Leverage internal experts in HSE and PSM to ensure risk reduction at contract manufacturers.
- Participate in HSE and PSM audits of contract manufacturing sites as applicable.
- Maintain key HSE and PSM metrics for review within API EM.
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