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Process Engineer - Manufacturing Investigations

Urbana, MD 21704

Posted: 07/16/2024 Employment Type: Contract Job Category: Engineering Job Number: 609742 Is job remote?: No Country: United States

Job Description


Target PR Range: 30-40/hr
*Based on experience

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.

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

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
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About Urbana, MD

Ready to take the next step in your career? Explore exciting job opportunities in the vibrant area surrounding Urbana, Maryland. Nestled in the heart of Frederick County, Urbana offers a perfect blend of small-town charm and big-city opportunities. From the picturesque views of Sugarloaf Mountain to the historic charm of downtown Frederick, this region boasts a wealth of scenic beauty and cultural richness. Indulge in the local cuisine at the famous Volt Restaurant, catch a performance at the Weinberg Center for the Arts, or explore the local art scene at the Delaplaine Arts Center. With easy access to outdoor recreational activities at the Monocacy National Battlefield and the Catoctin Mountain Park, Urbana provides an ideal backdrop for both personal growth and professional success. Discover your dream job in this thriving community today.

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