What are the responsibilities and job description for the MTO Technical Writer - Manufacturing Specialist position at System One?
Title: Technical Writer - Manufacturing Specialist
Pay Rate: $21/hr
Location: Harmons MD
Schedule: Monday through Friday 8-5 onsite
Duration: 12 months
Start: ASAP
Education:
Bachelor’s degree in a science or engineering field
Requirements:
- 4 years of demonstrated technical competency in biopharmaceutical manufacturing processing in a GMP compliance environment (e.g. Production, Development, Process Engineering, Technical Services or related field)
- 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
Responsibilities:
- Initiates Quality Records and conducts deviation investigations that meeting both Industry and Catalent expectations
- Leads or manage investigations including root cause analysis and assesses product impact using input from various departments
- Develops, executes and oversees CAPAs
-Technical leadership will be required to ensure that product and process understanding is sufficient to investigate deviations, that investigations are technically sound, meet quality expectations, and that corrective actions are effective.
- Supports Tech transfer and process monitoring support as needed
- Works with the team to monitor critical process parameters
- Revision and management of manufacturing documents such as Batch Records and SOPs
- Leads or supports Continuous Improvement projects
-Conducts data gathering, trending, and data presentation as needed to support investigations
- Responsible for real time, on the floor response in support of operational deviations by gathering information and completing an initial event report.
#m3
Pay Rate: $21/hr
Location: Harmons MD
Schedule: Monday through Friday 8-5 onsite
Duration: 12 months
Start: ASAP
Education:
Bachelor’s degree in a science or engineering field
Requirements:
- 4 years of demonstrated technical competency in biopharmaceutical manufacturing processing in a GMP compliance environment (e.g. Production, Development, Process Engineering, Technical Services or related field)
- 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
Responsibilities:
- Initiates Quality Records and conducts deviation investigations that meeting both Industry and Catalent expectations
- Leads or manage investigations including root cause analysis and assesses product impact using input from various departments
- Develops, executes and oversees CAPAs
-Technical leadership will be required to ensure that product and process understanding is sufficient to investigate deviations, that investigations are technically sound, meet quality expectations, and that corrective actions are effective.
- Supports Tech transfer and process monitoring support as needed
- Works with the team to monitor critical process parameters
- Revision and management of manufacturing documents such as Batch Records and SOPs
- Leads or supports Continuous Improvement projects
-Conducts data gathering, trending, and data presentation as needed to support investigations
- Responsible for real time, on the floor response in support of operational deviations by gathering information and completing an initial event report.
#m3
Salary : $21
