Process Engineer

Scorpion Therapeutics; Brooklyn Park (MN); On-site; USD 85,000 - 120,000; Full time

Job summary

Scorpion Therapeutics is seeking an engineering SME to support biopharmaceutical manufacturing processes, including cell culture, harvest, purification, and utilities. You will own system life cycles, develop PFDs and P&IDs, and lead modifications from design through commissioning.

Responsibilities cover FATs, CAPA investigations, asset management, and project execution within a strict cGMP and GEP framework.

Qualifications

• Bachelor's degree in Engineering (Chemical preferred).
• 0+ years of engineering experience in regulated biopharma or biotech manufacturing.
• Familiarity with bioreactors, chromatography, CIP, HVAC, and automation systems.
• Knowledge of GMP and industry best practices.

Responsibilities

• Oversee system lifecycle from design, qualification, to maintenance.
• Develop engineering deliverables (PFDs, P&IDs, specifications).
• Lead system modifications, FATs, commissioning, and CAPA investigations.
• Support system qualification, asset management, and project execution.
• Ensure compliance with cGMP and GEP standards; potentially serve as project manager for small capital projects.

Skills

Biopharma manufacturing

CIP

GMP knowledge

MS Office

Project management tools

Education

Bachelor's degree in Engineering (Chemical preferred)

Tools

PFDs & P&IDs

Job description

Role

Serve as the engineering subject matter expert for biopharmaceutical manufacturing support, focusing on process systems such as cell culture, harvest, purification, or utilities. Responsibilities: oversee system lifecycle from design, qualification, to maintenance; develop engineering deliverables (PFDs, P&IDs, specifications); lead system modifications, FATs, commissioning, and CAPA investigations; support system qualification, asset management, and project execution; ensure compliance with cGMP and GEP standards; potentially serve as project manager for small capital projects.

Requirements

Bachelor's degree in Engineering (Chemical preferred), with 0+ years of engineering experience, ideally within regulated biopharma or biotech manufacturing; familiarity with bioreactors, chromatography, CIP, HVAC, and automation systems; knowledge of GMP and industry best practices; proficiency in MS Office and project management tools.

Preferred

Engineer-in-Training (EIT) or Professional Engineer (PE) licensure; experience with FDA-regulated processes and biopharmaceutical equipment.

High-Value

Focus on manufacturing systems supporting biologics or cell/gene therapies, with emphasis on qualification, maintenance, and process support in a regulated environment.

Collaboration

Partner with cross-functional teams across manufacturing, quality, and engineering.

Work setup

Primarily on-site at Brooklyn Park, MN, with infrequent travel (~25%) and participation in 24/7 on-call support rotation. The role demands adherence to strict safety and quality protocols, including PPE usage.