Validation Engineer, Sterility & CQV

Summary

The Validation Engineer II, CQV Sterility Assurance supports the radiopharmaceutical facility and GMP operations in Indianapolis by drafting, executing, and maintaining commissioning, qualification, and validation documentation for facility, utility, analytical, laboratory, sterility assurance, and process systems. Supports validation lifecycle activities for aseptic manufacturing, environmental monitoring, analytical laboratory instrumentation, cleanroom performance qualification, and GMP study execution.

• 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 work streams 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.

• 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).

• Strong technical writing.
• Knowledge of regulatory validation guidance, lifecycle management, data integrity, documentation, and risk management.
• GMP, CQV, sterility assurance, contamination control, environmental monitoring, analytical instrumentation, and risk-based validation.
• Independent mindset, tenacity, sound judgment, attention to detail.
• Strong interpersonal, communication, problem-solving, data analysis, and planning skills.
• Proven ability working in GMP teams; multi-disciplined engineer with GMP experience.
• Professional ethics/integrity and ability to maintain confidential information.
• Uses AI tools to enhance productivity and quality of work.

• Health coverage; wellbeing support; 401(k), disability and life insurance, and related protections.
• Paid time off (flexible time off or annual vacation/holidays depending on employee group).