Process Engineer

Duration: 08+ Months (Extendable)

Pay Rate: $45.86/hr on W2 without benefitsYears of Experience: 3-7 yearsIndustry Experience: Biotech or Fluid Processing/ManufacturingEducation: B.S Chemical or Mechanical EngineeringGeneral 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 supervisor3. 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 Deliverables1. Investigate and Implement Process/Equipment/Automation Design Changes as a result of 5205/5208 FRASa. Changes driven through WorkFrontb. Own or Influence Changes driven through change controls2. 5220 Tech Transfer – OOF 08 Apr25a. Delivery and Designi. Recipe Development Design and Execution – Feb 25 ~20 daysii. Automation Configuration Specification Review & Approvaliii. Chrom Skid Flow Path Analysis Generation & Approvaliv. eBR Parameter Review & Approvalv. Batch Record Review & Approval3. 5209 Scale Lump Sum Closure4. Incorporate Flow processing and cleaning flow paths into equipment functional specifications5. Automate CS Drain Hand Valve for SMCC and XFER-73500 SIP Circuitsa. Change Control Ownershipb. Project Ownership & Execution