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.