Sr. Process Controls & Validation Engineer

Scorpion Therapeutics; Town of East Greenbush (NY); On-site; USD 90,000 - 130,000; Full time

Job summary

Scorpion Therapeutics is seeking a Process Validation Engineer to lead and support cGMP process validation, technology transfer, and scale-up activities. You will collaborate across Manufacturing, Quality Control, Quality Assurance, and CMC Regulatory to ensure lifecycle management and compliance.

The role requires a BS in Engineering with chemical or biomedical focus and 2+ years of experience in process validation, with Sr. level at 5+ years based on expertise.

Qualifications

• BS in Engineering; chemical engineering or biomedical engineering preferred.
• Process Controls & Validation Engineer: 2+ years experience (or Sr.: 5+ years experience; level based on experience)
• Experience with process validation, technology transfer, and scale-up for drug substance.

Responsibilities

• Lead and provide hands-on support for cGMP process validation (Stage 1–3) and lifecycle management.
• Support technology transfer, design transfer, and scale-up activities.
• Develop process control strategies and author protocols through execution and lifecycle management.

Skills

Process validation

Technology transfer

Scale-up

Statistics

Education

BS in Engineering (chemical or biomedical preferred)

Job description

Discover Your Role

• Leads and provides hands‑on support for cGMP process validation (Stage 1–3), technology transfer, design transfer, scale‑up, and process control strategy development (protocol authoring through execution and lifecycle management)
• Evaluates product/process risk and applies engineering judgment to resolve gaps and uncertainty from development to at‑scale manufacturing
• Analyzes process lifecycle data using statistics and engineering principles to inform control strategy/validation decisions and identify CPPs, control limits, and monitoring plans
• Leads and influences cross‑functional discussions with Manufacturing, Quality Control, Quality Assurance, and CMC Regulatory for process lifecycle management alignment
• Authors protocols, reports, and technical documents; ensures SOPs/policies/validation plans align with industry/regulatory expectations (e.g., ICH); supports audits/inspections and CMC regulatory submissions as needed
• Provides hands‑on support for laboratory and manufacturing‑scale studies

This Role Requires

• BS in Engineering; chemical engineering or biomedical engineering preferred
• Process Controls & Validation Engineer: 2+ years experience (or Sr.: 5+ years experience; level based on experience)
• Experience with process validation, technology transfer, and scale‑up for drug substance