Manufacturing Process Specialist

5 days ago


Severn, Maryland, United States Joulé Full time

Job Overview

Joulé is seeking an experienced Manufacturing Process Specialist to join our team.

Salary: $21/hour

Location: Maryland

Job Description:

The successful candidate will have a strong background in biopharmaceutical manufacturing and process control, with experience in GMP compliance environments.

The ideal candidate will possess excellent technical skills, including the ability to operate complex equipment such as incubators, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, single-use mixers, and in-process testing equipment.

A minimum of 4 years of experience in process deviation investigations and remediation is required, as well as 3+ years of experience in leading or managing investigations, root cause analysis, and product impact assessments.

Responsibilities:

  • Initiate quality records and conduct deviation investigations that meet industry expectations.
  • Lead or manage investigations, including root cause analysis and product impact assessments.
  • Develop, execute, and oversee CAPAs.
  • Provide technical leadership to ensure product and process understanding is sufficient to investigate deviations, that investigations are technically sound, meet quality expectations, and that corrective actions are effective.
  • Support tech transfer and process monitoring as needed.
  • Work with the team to monitor critical process parameters.
  • Revise and manage manufacturing documents such as batch records and SOPs.
  • Lead or support continuous improvement projects.
  • Conduct data gathering, trending, and data presentation as needed to support investigations.
  • Respond to operational deviations in real-time, gathering information and completing initial event reports.

Requirements:

  • Bachelor's degree in a science or engineering field.
  • 4+ years of demonstrated technical competency in biopharmaceutical manufacturing processing in a GMP compliance environment.
  • Previous experience operating equipment such as incubators, single-use bioreactors, depth filtration skids, TFF skids, chromatography skids, single-use mixers, and in-process testing equipment.
  • 3+ years of experience in process deviation investigations and remediation.


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