Senior Packaging Validation Engineer, Biotech GMP Final Drug Product

Senior Validation Engineer, Biotech GMP Final Drug Product3 Key Consulting is hiring!

We are recruiting a Senior Validation Engineer for a consulting engagement with our direct client, a leading global biotechnology company.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.Location Options: 100% Site Presence Required.

The position is expected to travel for approximately 10%.Job Description & ResponsibilitiesThe 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.Key responsibilities will include 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 Ohio commercial site and network with all stakeholders and deliver on technical deliverables.RelationshipThe Senior Validation Engineering is expected to build on the network expertise across the company 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.The Successful Candidate Will Have:Knowledge of high-speed, highly automated secondary packaging operationsKnowledge of the validation of equipment such as PFS assembly, cartoners, vision systemsExperience in writing protocolsExperience in executing protocolsCapable of executing multiple projectsCommunication skills and ability to work with other peopleBring innovative solutions for continuous process improvementExperience with KneatExperience with MiniTab is a plusTop Must Have Skill Sets:Packaging validation experienceKnowledge of packaging equipmentProtocol generation and executionDay to Day Responsibilities:Writing and executing validation protocols.Value proposition: Unique industry opportunity NetworkingBasic Qualifications: 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 experienceWhy is the Position Open?

Supplement additional workload on teamInterview Process: Initial screening with hiring manager Final interview panel with 3 interviewers