Process Engineer II — GMP Manufacturing & Process Innovator

Harland Medical Systems; Eden Prairie (MN); On-site; USD 85,000 - 110,000; Full time

Job summary

Harland Medical Systems in Eden Prairie, MN seeks a Process Engineer II to support operations in chemical manufacturing. You will design and optimize large-scale processes, create test methods, and develop documentation to meet regulatory standards.

The role requires hands-on troubleshooting, cross-functional collaboration, and a commitment to quality and continuous improvement. The candidate should have a BS in Chemical Engineering with 3+ years of applicable experience, familiarity with ISO

Qualifications

• Bachelor in Chemical Engineering with 3+ years related experience.
• ISO 13485 and/or 21 CFR Part 820 familiarity preferred.
• Strong analytical/problem-solving and ability to summarize/report technical info.
• Statistics knowledge with Minitab preferred.
• Experience with FT-IR, HPLC, and NMR preferred.
• LEAN/Sigma-Six manufacturing experience preferred.
• Self-starter, able to work independently and in a team.
• Detail-oriented and highly organized with multi-project capability.
• Excellent oral and written communication; proficient in MS Office.

Responsibilities

• Design and develop chemical manufacturing processes for large-scale production under FDA-compliant design controls.
• Create and validate new test methods.
• Produce design control documentation for product commercialization.
• Establish technical documentation for internal test plans and protocols.
• Present results to project leaders and team members clearly.
• Write and review manufacturing work instructions and forms.
• Revise documents/processes/methods for improvements.
• Initiate and process document change orders.
• Troubleshoot manufacturing issues.
• Support and/or perform other duties as required.

Skills

Analytical skills

Problem solving

Communication skills

Independent work

Team collaboration

Education

Bachelor of Science in Chemical Engineering

Tools

FT-IR

HPLC

NMR

Minitab

Job description

Harland Medical Systems in Eden Prairie, MN seeks a Process Engineer II to support operations in chemical manufacturing. You will design and optimize large-scale processes, create test methods, and develop documentation to meet regulatory standards.

The role requires hands-on troubleshooting, cross-functional collaboration, and a commitment to quality and continuous improvement. The candidate should have a BS in Chemical Engineering with 3+ years of applicable experience, familiarity with ISO