Process Engineer I

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

Role:

Process Engineer I or II supporting GMP manufacturing operations in the biopharma sector, focusing on equipment validation, maintenance, and compliance.

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

Requirements

• B.S. in Chemical, Electrical, Mechanical Engineering or related field
• Process Engineer I requires <2 years (or 4 years equivalent) experience, while Process Engineer II requires >2 years (or 6 years equivalent)
• strong communication skills
• experience in pharmaceutical or biotech GMP environment
• knowledge of FDA regulations and GMP systems

HighValue:

GMP manufacturing support in biopharma, equipment validation and maintenance, audit readiness, highly regulated environment, potential support for bioreactors, filtration, chromatography, and filling equipment, with a focus on compliance and quality assurance.