GMP Biopharma Process Engineer I - Equipment & Compliance

Scorpion Therapeutics; Durham (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Scorpion Therapeutics in Durham, North Carolina is seeking a Process Engineer I or II to support GMP manufacturing operations. You will work on equipment validation, preventative maintenance, calibrations, and modifications to maintain validated state, while collaborating with QA and manufacturing teams.

The role requires a BS in engineering, up to 6 years experience depending on level, strong communication, and familiarity with FDA regulations and GMP systems.

Qualifications

• B.S. in engineering required.
• Experience level depending on role: Engineer I <2 years (or 4 years equivalent); Engineer II >2 years (or 6 years equivalent).
• Experience in pharmaceutical or biotech GMP environment.

Responsibilities

• Ensure proper design and qualification of new equipment.
• Perform preventative maintenance, calibrations, and modifications to maintain validated state.
• Investigate deviations and implement corrective actions.
• Support audit and inspection activities as SME.
• Monitor equipment performance and evaluate new technologies.

Skills

Strong communication

GMP experience

FDA regulations knowledge

Biopharma equipment

Deviations investigation

Education

B.S. in Chemical, Electrical, or Mechanical Engineering or related field

Job description

Scorpion Therapeutics in Durham, North Carolina is seeking a Process Engineer I or II to support GMP manufacturing operations. You will work on equipment validation, preventative maintenance, calibrations, and modifications to maintain validated state, while collaborating with QA and manufacturing teams.

The role requires a BS in engineering, up to 6 years experience depending on level, strong communication, and familiarity with FDA regulations and GMP systems.