Job Description

Job Title: Process Engineer III

Location: 101 International Drive, Portsmouth, NH 03801

Duration: 8-month contract with the possibility of extension or conversion to full-time

About the Role:

We are seeking a Process Engineer III to support manufacturing operations, troubleshoot equipment and process issues, and drive continuous improvement initiatives. The ideal candidate will have a background in biotech or fluid processing/manufacturing and possess 3-7 years of experience in a similar role.

Key Responsibilities:

Manufacturing Support:

• Develop technical expertise in manufacturing equipment and processes.
• Troubleshoot and resolve major equipment breakdowns and quality issues.
• Provide subject matter expertise (SME) to Manufacturing and other departments on process equipment design and operation.
• Conduct technical analyses on manufacturing equipment and processes, including PI data reviews, CIP/SIP circuit analysis, and flow path evaluations.

Project Execution:

• Plan and execute plant projects involving equipment modifications and process improvements.
• Develop and execute commissioning protocols (installation, operation, CIP/SIP, wet testing) under supervision.

Documentation & Compliance:

• Review and revise SOPs, work instructions, and maintenance procedures based on CAPA, process changes, and error prevention strategies.
• Conduct engineering reviews and approvals for batch records.
• Initiate and manage Engineering Document Change Requests (EDCRs).
• Author commissioning protocols for equipment testing and validation.

Key Initiatives:

Process/Equipment/Automation Design Changes:

• Investigate and implement design changes for new customer first-run scale-ups.
• Drive and influence process changes through WorkFront and change control systems.

CAPEX Project Support:

• Buffer Valve Array Drain Hard Pipe: Manage funding requests and contractor coordination.
• IBF to SMCC Hardpipe: Oversee mechanical and automation scope, funding requests, and contractor collaboration.
• SMCC Filter Housing Upgrade: Lead mechanical and automation design changes while maintaining scope, schedule, and budget.
• EM Conflict Resolution: Identify and implement solutions for equipment conflicts, including automation modifications.
• VRF Skid Commissioning: Oversee installation and commissioning of new skid systems.

Qualifications:

• Education: Bachelor’s degree in Chemical or Mechanical Engineering.
• Experience: 3-7 years in biotech or fluid processing/manufacturing.
• Strong problem-solving, troubleshooting, and technical analysis skills.
• Experience with manufacturing process improvements and equipment modifications.

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