Sterility & CQV Validation Engineer (Aseptic GMP)

Scorpion Therapeutics; Indianapolis (IN); On-site; USD 85,000 - 125,000; Full time

Benefits offered by this job

Health coverage

401(k) and life insurance

Paid time off

Job summary

Scorpion Therapeutics is seeking a Validation Engineer II in Indianapolis to draft, execute, and maintain commissioning, qualification, and validation documentation for facility, utility, analytical, laboratory, sterility assurance, and process systems.

The role supports aseptic manufacturing, environmental monitoring, and analytical instrumentation validation, including cleanroom qualification and GMP study execution. 2–5 years in GMP and sterile environments is preferred.

Qualifications

• BS or MS in a scientific field (or equivalent experience).
• 2–5 years in radiopharmaceutical/sterile aseptic processing, analytical lab, QC, or GMP manufacturing environment.
• 2–5 years of validation experience in a GMP environment.
• Experience drafting/executing/reviewing qualification and validation protocols (preferred).

Responsibilities

• Support commissioning, qualification, and validation for GMP and supporting spaces.
• Develop, implement, execute, and maintain CQV strategies for facility, utility, analytical, laboratory, sterility assurance, and process systems.
• Support environmental monitoring, media fills, airflow visualization, cleanroom performance qualification, disinfection/sanitization validation, and VHP/bio-decontamination studies.
• Execute qualification for laboratory/analytical equipment (e.g., HPLC/UPLC, GC, UV-Vis, TOC, particle counters, endotoxin testing, microbiology equipment).
• Provide validation support including troubleshooting, data review, investigations, and validation impact assessments.
• Expand validation expertise (process validation, QC assets, cleaning validation, sterility assurance, analytical equipment qualification).
• Own/manage validation areas or workstreams and support validated state maintenance.
• Investigate deviations and review documentation for investigation, CAPA effectiveness, change control, inspection readiness, and validated state maintenance.
• Draft GMP documentation (SOPs, protocols, reports, deviations, CAPAs, change controls, test scripts).
• Support Health Authority inspections, internal audits, and KPI tracking.
• Mentor and cross-train team members.

Skills

Technical writing

Regulatory validation

GMP CQV

Environmental monitoring

Sterility assurance

Analytical instrumentation

Risk management

Cross-functional teamwork

Education

BS or MS in a scientific field

Tools

HPLC/UPLC

GC

UV-Vis

TOC

Job description

Scorpion Therapeutics is seeking a Validation Engineer II in Indianapolis to draft, execute, and maintain commissioning, qualification, and validation documentation for facility, utility, analytical, laboratory, sterility assurance, and process systems.

The role supports aseptic manufacturing, environmental monitoring, and analytical instrumentation validation, including cleanroom qualification and GMP study execution. 2–5 years in GMP and sterile environments is preferred.