Deputy Director, Process Engineering - Downstream

Swiftwater, PA, US
Posted 2 months ago by FPC Atlanta

Job Description

We are a global healthcare leader engaged in the research, development, manufacturing and marketing of therapeutic solutions focused on patients’ needs. We are looking for a Deputy Director Process Engineering - Downstream. Responsibilities will be to support manufacturing toward industrial excellence to guarantee the accuracy, conformity and competitiveness of the processes and techniques utilized for the production of the vaccines and biologics manufactured at our industrial sites. Duties will include:

· Process design and continuous improvements

· Support execution and documentation of development and/or validation studies as well as lead or supervise groups and/task force in the planning of engineering, investigational, definition and process validation runs within area of expertise.

· Document and interpret study results with recommendations

· Provide technical leadership as a subject matter expert in area of responsibility within site or global network

· Assist or lead the development and execution of training programs for appropriate audiences

· Comply with cGMP and other internal and external quality and regulatory guidance and health and safety guidelines.

· Provide leadership, including project team leadership, within area of expertise

· Execute life-cycle design and industrialization of downstream drug substance processes, products and associated test methods for Phase 3 and licensed products (new vaccines and biopharmaceuticals AND life-cycle improvements) to assure commercialization of robust, compliant, and efficient processes and test methods for vaccines and biopharmaceuticals.

· Input to design space / DOE studies through establishment of scale-up / scale-down parameters utilizing engineering fundamentals (mixing, mass / heat transfer, modeling, dimensionless parameters, etc.) and process control strategies.

· Partner with Engineering to ensure industrial implementation of process design, including review of engineering design documents; provide review and input to C&Q strategy and participating in testing of equipment.

· As a subject matter expert, provide technical assistance to manufacturing and quality operations for process troubleshooting, and health authority inspections to achieving site metrics.

· Expertise in one or more downstream process unit operation design typically used in biotech / vaccine manufacturing (chromatography, filtration, inactivation) as well as project / engineering lifecycle;

· Experience in equipment start-up, qualification and validation

· BS in Chemical or Biochemical Engineering

Contact: John Lonon

Recruiters Details

Swiftwater, PA, US
Job number:
John Lonon
Posted At:
2 months ago
Job Function:
Process Engineering
Biopharmaceutical /Biotechnology