Randstad Process Engineer in Framingham, Massachusetts
salary:$33.65 - $46.78 per hour
date posted:Tuesday, January 12, 2021
industry:Professional, Scientific, and Technical Services
A Process Engineer is needed for a global healthcare leader that discovers, develops and distributes therapeutic solutions focused on patient's needs in the Framingham, MA area. This job support ongoing manufacturing process and technical transfer projects for protein based biopharmaceutical as part of the Manufacturing Sciences team. Subject Matter Expert (SME) for development and validation, health authority inspections, and investigations.
location: Framingham, Massachusetts
job type: Contract
salary: $33.65 - 46.78 per hour
work hours: 8am to 5pm
Responsible for defining and supporting continuing validation program, process improvements, support execution and documentation of development and/or validation studies and contribute to quality event investigations, Document and interpret study results with recommendations.
Provide technical leadership as a subject matter expert in multiple areas of responsibility. participate in developing process control strategies.
Provide technical assistance to manufacturing and quality operations for process troubleshooting, and health authority inspections to achieving site metrics (+QDCI).
Expertise in downstream unit operation design typically used in biotech/vaccine manufacturing (harvest/clarification, UFDF, viral filtration and large scale Chromatography) .
Knowledge of computer software common to mission (Excel, JMP, Spotfire ) is preferred. strong experience in GMP environments.
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 & Education:
Experience in equipment start-up, qualification and validation is preferred.
Bachelor's Degree/Undergraduate Degree or Advanced Degree in chemical or biochemical engineering.
Degree in sciences with 3 years large scale process operational support, scale-up implementation & validation experience.
Experience level: Experienced
Minimum 3 years of experience
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
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