6 Process Engineer � Manufacturing Investigations Jobs in Frederick, MD
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Process Engineer � Manufacturing Investigations
$111k-129k (estimate)
Contractor
1 Day Ago
VARITE Inc. is Hiring a Process Engineer � Manufacturing Investigations Near Frederick, MD
Job Title: Process Engineer - Manufacturing InvestigationsLocation - Frederick, MDOnsiteSummarySeeking 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 Client's engineered T-Cell therapy products at the Frederick, Maryland site.
Responsibilities Include (but Are Not Limited To)
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 Client'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.
- 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
- 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
Job Summary
JOB TYPE
Contractor
SALARY
$111k-129k (estimate)
POST DATE
07/03/2024
EXPIRATION DATE
07/27/2024
WEBSITE
varite.com
HEADQUARTERS
San Jose, CA
SIZE
200 - 500
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