Scientist, TS/MS - Device Assembly
About The Position
Lilly is designing and building a new state of the art Parenteral, Device Assembly, and Packaging Facility located in Concord, North Carolina. This is an exciting opportunity to help build and operate a state-of-the-art manufacturing site and Quality System from the ground up. The Scientist within the Concord TS/MS Device Assembly process team is a position supporting the implementation of technical objectives through execution activities and partnership with the device assembly operations and engineering teams. This role will initially supplement the delivery of automated device assembly lines and serve as technical resource for internal parties. Upon the start of commercial production, this role’s objectives include analyzing equipment/process data, monitoring production metrics, authoring and executing protocols, and serving as a technical asset for process improvement and root cause investigations. This role is expected to interface regularly with the device assembly operations and engineering teams in support of day-to-day operations.
Requirements
- Bachelors or equivalent (Science or Engineering related degree preferred)
- 2+ years experience in a manufacturing organization
Nice To Haves
- Pharmaceutical and/or medical device manufacturing experience
- Root cause investigation experience
- Proven ability to work independently or as part of a team to resolve an issue.
- Strong attention to detail.
- Proficiency with computer systems including Microsoft Office products, Veeva Vault, TrackWise, electronic batch records, and SAP.
- Knowledge and understanding of manufacturing processes.
- Strong interpersonal and teamwork skills
- Strong self-management and organizational skills
Responsibilities
- Support the Device Assembly Process Team as TS/MS representative.
- Serve as floor-level support and technical interface for device components, equipment, and operations for the TSMS team.
- Provide technical support to non-routine (e.g., deviation, complaint) investigations, including consultation on quality and stability issues.
- Represent Concord TSMS team for internal and external communications on a regular basis
- Lead risk management activities as it pertains to product/process.
- Prepare and Review, as required, relevant technical documents, such as: Change Controls, Regulatory Submissions, Deviations, Validations, Protocols, Procedures, PFDs, pFEMAs, etc.
- Develop, monitor, and appropriately react to established statistically based metrics in real-time to assess process variability and capability.
- Identify opportunities and lead technical projects to improve process control and/or productivity
- Serve as interface with upstream suppliers and global device/drug product networks
- Drive stability strategy for Concord products.
- Provide Audit support as needed.
- Identify opportunities and participate in projects to improve process control and/or productivity.
Benefits
- company bonus (depending, in part, on company and individual performance)
- company-sponsored 401(k)
- pension
- vacation benefits
- medical, dental, vision and prescription drug benefits
- flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
- life insurance and death benefits
- certain time off and leave of absence benefits
- well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
