Job Description

Years of Experience: 3-7 years
Industry Experience: Biotech or Fluid Processing/Manufacturing
Education: B.S Chemical or Mechanical Engineering

1. Support Investigation and Implementation of Process/Equipment/Automation Design Changes as a result of new customer first run at scale runs

2. CAPEX Project Support

General Deliverables

1. Manufacturing Support
• Develop technical knowledge on manufacturing equipment and processes
• Support resolution of major equipment breakdowns and quality issues in the suites
• Provide SME support to Manufacturing and other departments for the
• design and operation of process equipment.
• Conduct troubleshooting and technical analyses on manufacturing equipment and processes including PI data analyses, CIP/SIP circuit review, MOC analyses, flow path analyses, etc.

2. Projects
• Planning and execution of plant projects involving equipment changes and process improvements.
• Execute commissioning protocols (installation, operation, CIP/SIP, wet
• testing) with support and guidance from supervisor

3. Documentation
• Review/revise Engineering and Manufacturing related SOP’s, work instructions, and maintenance assessments/procedures as a result of CAPA, equipment/process changes, error prevention activities, etc.
• Complete engineering review/approval of batch records
• Initiate EDCRs for updates to Engineering documents including engineering drawings
• Author commissioning protocols (installation, operation, CIP/SIP, wet testing).

Additional Information

All your information will be kept confidential according to EEO guidelines.