Manufacturing Engineer - Process Scale-Up & Validation

Planet Pharma; Woburn (MA); On-site; USD 70,000 - 100,000; Full time

Job summary

Planet Pharma in Woburn, MA is seeking a Manufacturing Engineer to own engineering support for manufacturing operations, taking processes from specification and validation through scale-up and continuous improvement while staying compliant with FDA QMSR and ISO 13485.

You will set up new processes, lead scale-up to hit targets for yield, capacity, and productivity; design lean production lines; coordinate with R&D, Quality and Operations to move products from development to production.

Qualifications

• Bachelor’s degree in engineering or equivalent.
• 1+ years in a manufacturing or process engineering role, preferably in medical devices.
• Hands-on experience with process validation (IQ/OQ/PQ) and equipment qualification.
• Strong technical writing, with ability to produce protocols and reports.
• Able to move between hands-on work and guiding technicians and cross-functional partners.

Responsibilities

• Set up new manufacturing processes and improve existing ones.
• Lead scale-up and commercialization to hit targets for yield and throughput.
• Design lean production lines focusing on flow and layout.
• Provide daily engineering support to Production and ensure regulatory compliance.
• Train product builders and transfer knowledge for new processes.

Skills

Manufacturing experience

Process engineering

Technical writing

Cross-functional collaboration

Education

Bachelor's degree in engineering

Tools

IQ/OQ/PQ protocols

Factory Acceptance Tests (FATs)

pFMEA

Job description

Planet Pharma in Woburn, MA is seeking a Manufacturing Engineer to own engineering support for manufacturing operations, taking processes from specification and validation through scale-up and continuous improvement while staying compliant with FDA QMSR and ISO 13485.

You will set up new processes, lead scale-up to hit targets for yield, capacity, and productivity; design lean production lines; coordinate with R&D, Quality and Operations to move products from development to production.