Hybrid Process Validation Engineer – Gene Therapy

Lancesoft; Carlsbad (CA); Hybrid; USD 120.000 - 160.000; Vollzeit

Zusammenfassung

Lancesoft is seeking a Process Validation Engineer for the Carlsbad gene therapy viral vector facility. You will develop, review, and manage validation activities and serve as SME for process validation across unit operations, interfacing with Manufacturing, Quality, and Project Management.

Responsibilities include risk assessments, protocol generation, data interpretation, and cross-functional leadership to ensure compliant, robust validation strategies within a fast-paced CDMO environment.

Qualifikationen

• BLA filing experience with FDA/regulatory agencies.
• Minimum 7+ years in a cGMP environment.
• Process validation, PPQ and CPV experience.

Aufgaben

• Write risk assessments for manufacturing processes and facilities.
• Create and review validation documentation to ensure validated parameters.
• Monitor events and propose corrective actions to avoid repeats.
• Lead cross-functional validation studies and coordinate with stakeholders.
• Evaluate equipment/process problems and design tests for root cause analysis.

Kenntnisse

BLA filing experience

Commercial manufacturing

Validation activities management

Ausbildung

Bachelor's or Master's degree in Biochemistry, Chemistry, Chemical Engineering, Microbiology, or Life Science

Jobbeschreibung

Lancesoft is seeking a Process Validation Engineer for the Carlsbad gene therapy viral vector facility. You will develop, review, and manage validation activities and serve as SME for process validation across unit operations, interfacing with Manufacturing, Quality, and Project Management.

Responsibilities include risk assessments, protocol generation, data interpretation, and cross-functional leadership to ensure compliant, robust validation strategies within a fast-paced CDMO environment.