Senior Process Engineer - GMP Validation & Optimization

Scorpion Therapeutics; New Jersey; On-site; USD 95,000 - 140,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k) plan

Job summary

Scorpion Therapeutics is seeking a technically skilled professional to provide cross-functional technical support in a GMP environment, guiding projects from concept through to closure with minimal supervision.

You will lead process engineering activities (PV, Cleaning Validation, IQ/OQ/PQ), troubleshoot production issues, and evaluate changes, while collaborating with manufacturing, quality, and engineering teams to ensure compliant, scalable processes.

Qualifications

• Bachelor's in Engineering/Science or equivalent experience; 5+ years in engineering/operational roles.
• Strong technical knowledge and judgment on complex problems.
• Collaborative communication and interpersonal/negotiation skills.
• Technical background in medical devices, pharmaceutical, biologics, or similar industries.
• Experience with financial systems and fiscal control.
• Preferred: 5+ years Process Engineering in GMP operations; Cleaning Validation and IQ/OQ/PQ.

Responsibilities

• Lead process engineering activities (Process Validation, Cleaning Validation, IQ/OQ/PQ, root-cause investigations).
• Support/monitor Production to troubleshoot material, process, and equipment issues; analyze data using structured techniques, data acquisition, process capability analysis, SPC, and other statistics.
• Provide technical evaluations for Engineering Change Orders and Supplier Changes (updates to specs/drawings/procedures; operator training).
• Design/develop equipment and processes for manufacturing; design/build/qualify fixtures, machines, or equipment.
• Support integration of new products into manufacturing (materials, processing, manufacture, cost inputs).
• Assist in validation of new/revised processes and equipment to meet standards/specifications.
• Design and execute engineering studies to test project hypotheses.
• Apply scientific/technical knowledge for timely execution; may supervise engineers/technicians.

Skills

Engineering knowledge

Statistical analysis

Collaboration

Project management

Communication

Problem solving

Education

Bachelor's degree in Engineering or Science

Post-graduate degree

Job description

Scorpion Therapeutics is seeking a technically skilled professional to provide cross-functional technical support in a GMP environment, guiding projects from concept through to closure with minimal supervision.

You will lead process engineering activities (PV, Cleaning Validation, IQ/OQ/PQ), troubleshoot production issues, and evaluate changes, while collaborating with manufacturing, quality, and engineering teams to ensure compliant, scalable processes.