Mechanical Engineer - SGS Consulting
Portsmouth, NH 00215
About the Job
Job Title: | Process Engineer III |
Duration: | 08 Months+ (Possible Extension) |
Location: | Portsmouth, NH 03801 (Onsite) |
Schedule: | Business Hours |
Job Description:
- Years of Experience: 3-7 years
- Industry Experience: Biotech or Fluid Processing/Manufacturing
- Education: B.S Chemical or Mechanical Engineering
General Deliverables:
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.
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.
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).
- Specific Deliverables
Responsibilities:
- Investigate and Implement Process/Equipment/Automation Design Changes as a result of 5205/5208 FRAS
- Changes driven through WorkFront
- Own or Influence Changes driven through change controls
- 5220 Tech Transfer OOF 08Apr25
- Delivery and Design
- Recipe Development Design and Execution Feb 25 ~20 days
- Automation Configuration Specification Review & Approval
- Chrom Skid Flow Path Analysis Generation & Approval
- eBR Parameter Review & Approval
- Batch Record Review & Approval
- 5209 Scale Lump Sum Closure
- Incorporate Flow processing and cleaning flow paths into equipment functional specifications
- Automate CS Drain Hand Valve for SMCC and XFER-73500 SIP Circuits
- Change Control Ownership
- Project Ownership & Execution
Source : SGS Consulting
