Title: Process Engineer - Manufacturing Investigations
Location: Frederick, MD-Onsite
Duration: 12 months contract
Pay Rate:$35/hr to $41/hr
Description:
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 engineered T-Cell therapy products at the Frederick, Maryland site.
Key Responsibilities: • 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
o AA in Biochemical Engineering, Chemical Engineering, Biotechnology, Chemistry, Biology, or equivalent with at least 6 years of relevant experience or
o HS 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
To know more about current opportunities at LeadStack, please visit us at https://leadstackinc.com/careers/
Should you have any questions, feel free to call me on (415) 322-5419or send an email on akarsh.yathiraj@leadstackinc.com