Excellent employment opportunity for a Process Engineer - Manufacturing Investigations in the Frederick, MD area. Onsite
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.
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.
Experience:
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
High School Diploma with 8 years of relevant experience in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent
Preferred Qualifications: • Strong skill in technical writing • Strong skill in organization • Strong skill in root cause analysis • Experience in cell culture or aseptic processing • Experience in cGMP cell therapy manufacturing