Process Engineer III
Senior Process Engineer, Manufacturing Technology
Location: Framingham, MA (01701)
Contract Length: 4 months (with possibility of extension)
Description:
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.
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).
Required Experience:
Bachelor's Degree/Undergraduate Degree or Advanced Degree in chemical or biochemical engineering.
Minimum of 3 years experience with large scale process operational support, scale-up implementation & validation experience.
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 in equipment start-up, qualification and validation is preferred.
Knowledge of computer software common to mission (Excel, JMP, Spotfire ) is preferred.
Experis is an Equal Opportunity Employer
Job Type:Contract
Location:Framingham, MADistance:19 miles
Date Posted:Aug 19, 202034 days ago
Industry:Health and Safety
Senior Process Engineer, Manufacturing Technology
Location: Framingham, MA (01701)
Contract Length: 4 months (with possibility of extension)
Description:
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.
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).
Required Experience:
Bachelor's Degree/Undergraduate Degree or Advanced Degree in chemical or biochemical engineering.
Minimum of 3 years experience with large scale process operational support, scale-up implementation & validation experience.
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 in equipment start-up, qualification and validation is preferred.
Knowledge of computer software common to mission (Excel, JMP, Spotfire ) is preferred.
Experis is an Equal Opportunity Employer