Senior Packaging Validation Engineer, Biotech GMP Final Drug Product (JP14454)
About The Position
This position requires the application of diverse and advanced engineering and scientific principles in support of commercial GMP Final Drug Product (FDP) operations. The Senior Validation Engineering will support the development and implementation of automated and semi-automated combination product assembly equipment initiatives as part of the Finished Drug Product (FDP) product portfolio at the Ohio manufacturing site. The position is a key role in the Process Development team where the candidate must manage and/or apply extensive technical expertise (characterization, validation and troubleshooting) in the validation of combination products. This position also requires the application of advance and diverse engineering principles to more than one area of engineering (process, unit operations, equipment, devices and materials) in complex process optimization, scale up and manufacturing support projects.
Requirements
- Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience
- Knowledge of high-speed, highly automated secondary packaging operations
- Knowledge of the validation of equipment such as PFS assembly, cartoners, vision systems
- Experience in writing protocols
- Experience in executing protocols
- Capable of executing multiple projects
- Communication skills and ability to work with other people
- Bring innovative solutions for continuous process improvement
- packaging validation experience
- knowledge of packaging equipment
- protocol generation and execution
Nice To Haves
- Experience with Kneat
- Experience with MiniTab is a plus
Responsibilities
- Supporting the packaging C&Q activities of the product portfolio to AOH.
- Provision of technical operations support for the continuous improvement of device assembly and packaging line capacity and performance.
- Advisory of technical improvement projects.
- Ensure effective communication throughout the Ohio commercial site and network with all stakeholders and deliver on technical deliverables.
- Build on the network expertise across the company commercial and clinical operations for product assembly, label and packaging.
- Leverage this network in support of GMP technical expertise, performance trending, equipment standardization and troubleshooting/process.
- Writing and executing validation protocols.
Benefits
- W2 with benefits
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
