Process Validation Engineer

Looking for an experienced Process Validation Specialist, in the Manufacturing Technology (MTech) function of M&S-V, is 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 the Sanofi industrial sites. The mission of MTech is to deliver robust and efficient process & testing with associated know-how transfer to Manufacturing & Quality Control (QC). MTech’s function also provides daily support, for manufacturing and QC, toward industrial performance excellence. Key contributor for strategy development and execution of development and process validation related to viral vaccine manufacture. Provides input to industrialization strategies and rationale for critical process parameters. Subject Matter Expert (SME) for development and validation, health authority inspections, and investigations. The individual in this position will work with a cross-functional team from various functions in M&S-V to deliver following: The Job Responsibilities Include: Write protocols, reports, procedures and memos as needed to support viral vaccine drug substance manufacturing activities (upstream processes, downstream purification, products and associated test methods) as they relate to engineering, investigational, definition, development and process validation runs Support execution and documentation of engineering, development and/or validation studies and lead or supervise groups and/task force in the planning of engineering, investigational, definition, development and process validation runs. 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 Education and experience Basic Qualifications: BS or MS in basic sciences, math, engineering or pharmacy with 2+ years’ experience or PhD with experience in biological processes or analytics in a cGMP environment. Preferred Skills: Expertise in one or more upstream/downstream process unit operation design typically used in biotech / vaccine manufacturing (seed expansion, viral growth and cell culture egg processes, harvest / clarification, purification, sterile filtration) as well as project / engineering lifecycle. Proficient with structured methodologies such as Good Engineering Practices, Quality by Design, Design Space, & Process Control Strategies to be employed in the course of industrial process design, validation and control. Ability to work in cross functional teams, provide strong analytical skills for troubleshooting and root cause analysis, and communicate with internal and external team members. Experience in equipment start-up, qualification and validation is preferred. Prior experience preparing and executing process performance qualification documents (PPQ) preferred. Job Types: Full-time, Contract Pay: Up to $55.00 per hour Ability to commute/relocate: Bellefonte, PA 16823: Reliably commute or planning to relocate before starting work (Required) Education: Bachelor's (Required) Experience: Subject Matter Expert: 2 years (Required) MTech: 2 years (Required) Quality control: 3 years (Required) Manufacturing: 2 years (Required) engineering lifecycle: 3 years (Required) performance qualification documents (PPQ): 2 years (Required) validation: 2 years (Required) Biotechnology: 3 years (Required) Work Location: In person