Senior Validation Engineer

Aditi Consulting

  • New Albany, OH
  • Permanent
  • Full-time
  • 7 days ago
Payrate: $53.00 - $55.00/hr.Summary:
The Senior Validation Engineer position reports into the Sr. Manager of Validation. This position requires the application of diverse and advanced engineering and scientific principles in support of commercial GMP Final Drug Product (FDP) operations.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.Responsibilities:
  • Supporting the packaging C&Q activities of the product portfolio to AOH.
  • Additional responsibilities will include the provision of technical operations support for the continuous improvement of device assembly and packaging line capacity and performance, and advisory of technical improvement projects.
  • The Sr. Validation Engineer must ensure effective communication throughout the commercial site and network with all stakeholders and deliver on technical deliverables.
  • The position is expected to leverage this network in support of GMP technical expertise, performance trending, equipment standardization and troubleshooting/process improvements at AOH.
Qualifications:
  • 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
  • Experience with Kneat
  • Experience with MiniTab is a plus
Desired Skills:
  • Packaging validation experience
  • Knowledge of packaging equipment
  • Protocol generation and execution
Pay Transparency: The typical base pay for this role across the U.S. is: $53.00 - $55.00/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy ( ).Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. By applying for this position, you agree to Aditi’s use of AI technology, including calls from an AI Voice Recruiter.#AditiConsulting
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Aditi Consulting