Pharma
Years of Experience: 3-7 years
Industry Experience: Biotech or Fluid Processing/Manufacturing
Education: B.S Chemical or Mechanical Engineering
1. Support Investigation and Implementation of Process/Equipment/Automation Design Changes as a result of new customer first run at scale runs
2. CAPEX Project Support
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).
All your information will be kept confidential according to EEO guidelines.
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Are you a talented Process Engineer looking to make your mark in the biotech industry? Join us at our cutting-edge facility in Portsmouth, NH, where you'll be part of a dynamic team dedicated to innovating and improving biopharmaceutical manufacturing processes. As a Process Engineer at our pharmaceutical company, you'll leverage your 3-7 years of industry experience and your degree in Chemical or Mechanical Engineering to implement and support process changes for new customer runs. Your role will include technical troubleshooting, commissioning protocols, and interaction with manufacturing teams to resolve equipment breakdowns or quality issues efficiently. You'll be hands-on in planning and executing plant projects that involve both equipment changes and process enhancements, gaining in-depth knowledge of our manufacturing equipment and processes. Additionally, you'll play a key role in the documentation process, reviewing and revising Standard Operating Procedures (SOPs), and initiating necessary documentation updates. If you're ready to contribute to significant advancements in biotech and work in a collaborative and supportive environment, we want to hear from you!
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