Process Engineer 2

Scorpion Therapeutics; Redmond (WA); On-site; USD 83,000 - 86,000; Full time

Benefits offered by this job

Medical/Dental/Vision

Annual bonus

401k match

PTO & holidays

Wellness program

Flexible on-site work

Job summary

Scorpion Therapeutics is seeking a Process Engineer to advance biologics manufacturing capabilities. You will evaluate technologies, design and validate workflows, and drive integration of equipment into the DCS with the manufacturing suite.

The role requires 2–5 years in pharma/biotech with cGMP knowledge and experience in monoclonal antibody processing. You will partner with global teams, lead lifecycle plans for equipment, and support audits and continuous improvement initiatives across the

Qualifications

• BS in engineering or related life sciences with 2–5 years in pharma/biotech.
• Working knowledge of cGMP regulatory requirements.
• Understanding of monoclonal antibody processing.
• Experience with single-use disposable manufacturing systems.
• Ability to work independently and cross-functionally; strong time management.
• Ability to organize, analyze/interpret, and communicate process data.
• Excellent oral and written communication.

Responsibilities

• Evaluate technologies to increase efficiency and facility throughput.
• Develop design documents and support validation/qualification protocols.
• Assist with integrating equipment into the DCS with the manufacturing suite.
• Evaluate single-use technologies and design manifolds/assemblies.
• Work with vendors on data and validation packages.
• Lead procurement and implementation of new technologies.
• Develop SOPs and training for equipment/technologies.
• Lead equipment maintenance and lifecycle plans.
• Support global/site objectives with MSAT Manufacturing Technology & Science.
• Assist with non-conformance investigations and process impact evaluations.
• Participate in audits and technical problem/solution exchanges.

Skills

Cross-functional collaboration

Data analysis

Communication

Project management

Quality/compliance

Education

BS in engineering or life sciences

MS degree

Tools

DeltaV automation

Job description

Responsibilities

• - Work with stakeholders to evaluate new/existing technologies to increase efficiency and facility throughput.


• - Develop design documents (user requirement and software functional specifications) and support validation, commissioning, and qualification protocols.


• - Assist with integrating equipment/technologies into the Distribute Control System (DCS) with the manufacturing suite.


• - Evaluate single-use technologies; design single-use manifolds and assemblies.


• - Work with vendors to develop data and validation packages.


• - Facilitate procurement and implementation of approved new technologies.


• - Develop business processes, guidelines, SOPs, and training for processing equipment/technologies.


• - Lead equipment maintenance and life cycle plans.


• - Partner with Site MSAT Manufacturing Technology & Science on global/site objectives.


• - Support non-conformance/deviation investigations and provide process impact evaluations.


• - Participate in technical problem/solution exchanges and internal/external audits/inspections.

Position Requirements

• - BS in engineering/sciences/related life science engineering with 2–5 years relevant experience in pharma/biotech/life sciences, or an MS degree.


• - Working knowledge of cGMP and regulatory requirements for biologics/pharmaceuticals.


• - Solid understanding of monoclonal antibody processing (manufacturing scale or process development).


• - Experience with single-use disposable manufacturing systems.


• - Ability to work independently and cross-functionally; quality/attention to detail; strong task/time management.


• - Ability to organize, analyze/interpret, and communicate process data.


• - Excellent oral and written communication.

Additional Preferred Qualifications

• - Continuous manufacturing experience; DeltaV automation.


• - Experience in global teams/centers of excellence.


• - CQV plan/protocol development and execution.


• - Ability to lead projects within functional expertise.

Benefits/Pay (as stated)

• - base pay $83,000–$86,250; discretionary annual bonus; Medical/Dental/Vision; short- and long-term disability; basic life insurance; 401k match; flexible site-based work; paid time off/holidays; wellness and transportation.