Validation Engineer Senior

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 in the Client Ohio facility.

Location Options: AOH. 100% Site Presence Required.

The position is expected to travel for approximately 10%.

FUNCTIONS

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 Client 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.

OUTPUTS

Key responsibilities will include supporting the packaging C&Q activities of the Client 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 Client Ohio commercial site and Client network with all stakeholders and deliver on technical deliverables.

RELATIONSHIPS

The Senior Validation Engineering is expected to build on the Client network expertise across the Client commercial and clinical operations for product assembly, label and packaging. The position is expected to leverage this network in support of GMP technical expertise, performance trending, equipment standardization and troubleshooting/process improvements at AOH.

JOB SPECIFICATIONS

Competencies/Skills:

The successful candidate will have:

• 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