The Quality Engineer is an associate with high level of expertise and experience with general biopharmaceutical manufacturing equipment, principles and processes and has a strong understanding of current GXPs, safety, and regulatory standards.
The QE will work closely with QC to provide support for Validation, Maintenance, Engineering, Automation, Metrology, Manufacturing Sciences, Lab operations, and QA Compliance teams.
The QE collaborates with subject matter experts and technical specialists to provide Quality oversight for operation of a cGMP compliant Manufacturing facility and QC Lab Operations with quality assurance needs as defined by departmental management.
The QE will be responsible for providing QA support in facility, utility, equipment, and QC Analytical Instrumentation activities for sites primarily located at Cambridge and Somerville MA, and as needed Alachua FL.
Activities include validation, change control, equipment maintenance, automation, and QA capital projects.
Must have strong knowledge of 21 CFR, ICH, and EU regulations
Must possess strong knowledge of QbD, Risk Based approach, and performing Risk Assessments
EDUCATION AND QUALIFICATIONS:
Bachelor s Degree in Sciences or Engineering Minimum 5 years industry related experience with a Bachelor s Degree Strong interpersonal and communications skills; written and oral Solid understanding of applicable regulatory requirements
Corporate / senior
Cambridge , United States