Job Title: Process Engineer I - Manufacturing Investigations
ONSITE : Frederick, Maryland
***ONLY_W2 and Local Candidates can apply***
Company is seeking a highly motivated individual with biotechnology experience to work on innovative T-Cell therapies for cancer treatment.
As a member of the Operations and Compliance Support team, you will be part of a team of investigators responsible for the examination and resolution of adverse events (quality events) that occur within manufacturing operations for Company's engineered T-Cell therapy products at the
Frederick, Maryland site.
Responsibilities Include (but are not limited to):
Complete required training to maintain technical skill, knowledge, and compliance with cGMP requirements.
Initiate quality records in the Veeva Quality Management System (QMS).
Lead cross-function team meetings to perform complex root cause analysis (RCA).
Compile investigation results in a concise and comprehensive technical report format.
Collaborate with stakeholders to develop Corrective and Preventive Actions (CAPA).
Manage investigation timelines to meet/exceed site compliance metrics for closure adherence.
Provide timely progress updates to internal stakeholders, as required.
Basic Qualifications:
BS or BA in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with at least 2 years of relevant experience or
AA in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with at least 6 years of relevant experience or
HS Diploma with 8 years of relevant experience in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent