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Process Engineer III

4 weeks ago

Portsmouth, Virginia, United States Planet Pharma Full time
Job Title: Process Engineer III

Planet Pharma is seeking a highly skilled Process Engineer III to join our team in Portsmouth, NH.

Job Summary:

We are looking for a Process Engineer III with 3-7 years of experience in biotech or fluid processing/manufacturing to support our manufacturing operations. The ideal candidate will have a strong background in chemical or mechanical engineering and excellent technical knowledge of manufacturing equipment and processes.

Key Responsibilities:

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