Process Engineer III - Tailored Management
Portsmouth, NH 03801
About the Job
Years of Experience: 3-7 years
Industry Experience: Biotech or Fluid Processing/Manufacturing
Education: B.S Chemical or Mechanical Engineering
Cost Center: 63042
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
Industry Experience: Biotech or Fluid Processing/Manufacturing
Education: B.S Chemical or Mechanical Engineering
Cost Center: 63042
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
Source : Tailored Management
