Process Engineer III
1 month ago
Portsmouth, NH (Onsite)
8 Month Contract
Pay: $35-45/hr
Job Description:
Years of Experience: 3-7 years
Industry Experience: Biotech or Fluid Processing/Manufacturing
Education: B.S Chemical or Mechanical Engineering
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).
Specific Deliverables
1. Investigate and Implement Process/Equipment/Automation Design Changes as a result of 5205/5208 FRAS
a. Changes driven through WorkFront
b. Own or Influence Changes driven through change controls
2. 5220 Tech Transfer – OOF 08Apr25
a. Delivery and Design
i. Recipe Development Design and Execution – Feb 25 ~20 days
ii. Automation Configuration Specification Review & Approval
iii. Chrom Skid Flow Path Analysis Generation & Approval
iv. eBR Parameter Review & Approval
v. Batch Record Review & Approval
3. 5209 Scale Lump Sum Closure
4. Incorporate Flow processing and cleaning flow paths into equipment functional specifications
5. Automate CS Drain Hand Valve for SMCC and XFER-73500 SIP Circuits
a. Change Control Ownership
b. Project Ownership & Execution
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