Pharma Process Engineer - Start-Up & CI Excellence

Seranbio; Bend (OR); On-site; USD 110,000 - 165,000; Full time

Benefits offered by this job

Paid time off

Retirement plan

Health plans

Life insurance

Long-term disability

Employee assistance program

Pet insurance

Job summary

Serán BioScience seeks a seasoned Process Engineer to drive the startup and commissioning of process systems for our new Bend, Oregon manufacturing operations. You will lead process design, qualification, and readiness activities to ensure cGMP compliance and efficient production.

The role emphasizes Lean Six Sigma, process optimization, and collaboration with Validation, QA, and Manufacturing to support tech transfer and ongoing improvements.

Qualifications

• BS/MS in Industrial, Chemical, or Mechanical Engineering.
• 8+ years in pharmaceutical manufacturing, process engineering, or industrial engineering.
• Hands-on experience with facility start-up, commissioning, and equipment qualification.
• Strong knowledge of cGMP requirements and commercial manufacturing operations.

Responsibilities

• Lead design and engineering for new process equipment installations.
• Oversee commissioning and qualification activities (URS, FAT, IQ/OQ/PQ).
• Coordinate with vendors and contractors for startup of manufacturing systems.
• Drive Lean and Six Sigma to reduce waste and improve process reliability.
• Support process validation and GMP documentation.
• Develop readiness plans and cross-functional collaboration.
• Lead CI projects to sustain efficiency and compliance.
• Draft and review SOPs for new processes.

Skills

Industrial Engineering

Chemical Engineering

Process Engineering

Lean Six Sigma

cGMP knowledge

Project Management

Data analysis

Documentation

Communication

Education

Industrial Engineering

Chemical Engineering

Mechanical Engineering

Job description

Serán BioScience seeks a seasoned Process Engineer to drive the startup and commissioning of process systems for our new Bend, Oregon manufacturing operations. You will lead process design, qualification, and readiness activities to ensure cGMP compliance and efficient production.

The role emphasizes Lean Six Sigma, process optimization, and collaboration with Validation, QA, and Manufacturing to support tech transfer and ongoing improvements.