Validation Engineer Senior

About Client:

The client is one of the world's largest independent biotechnology companies, focusing on the discovery, development, and manufacturing of innovative human therapeutics. The company's areas of expertise include oncology, hematology, cardiovascular disease, inflammation, bone health, and neuroscience.

It has developed a wide range of biologic medicines, including biotechnology drugs, therapeutic antibodies, and other innovative therapies. The company collaborates with academic institutions, biotechnology partners, and other organizations to advance its research efforts.

Rate: $60.69/Hr

Job Description:

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 *** Ohio facility. Responsibilities:

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. OUTPUTS

Key responsibilities will include supporting the packaging C&Q activities of the *** product portfolio to AOH.

dditional 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. RELATIONSHIPS

The Senior Validation Engineering is expected to build on the *** network expertise across the *** 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. Competencies/Skills:

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

Non-benefitted (other than those mandated under state or federal law).Please note that this position does not include paid time off benefits. ApTask offers subsidized insurance coverage to our employees.

About ApTask:

ApTask is a leading global provider of workforce solutions and talent acquisition services, dedicated to shaping the future of work. As an African American-owned and Veteran-certified company, ApTask offers a comprehensive suite of services, including staffing and recruitment solutions, managed services, IT consulting, and project management. With a focus on excellence, collaboration, and innovation, ApTask provides unparalleled opportunities for professional growth and development. As a member of the ApTask team, you will have the chance to connect businesses with top-tier professionals, optimize workforce performance, and drive success across diverse industries. Join us at ApTask and be part of our mission to empower organizations to thrive while fostering a diverse and inclusive work environment.

Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview.

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