Senior Validation Engineer - GMP Biotech (Onsite NC)

Piper Companies; Clayton (NC); Vor Ort; USD 102.000 - 116.000; Vollzeit

Benefits dieser Stelle

Comprehensive Benefits: Medical,Dental

Sick leave and 401K

Zusammenfassung

Piper Companies is seeking a Senior Validation Engineer for an onsite contract in Clayton, NC. The role leads validation activities across automated manufacturing systems in a GMP environment, supporting large-scale pharmaceutical projects, and coordinating cross-functional teams.

The position requires a strong foundation in validation, regulatory compliance, and project leadership, with experience in IV/OV/PV testing and change control processes.

Qualifikationen

• Knowledge of GMP requirements and regulatory expectations.
• Experience validating automated manufacturing equipment and systems.
• Proven ability to lead validation projects and cross-functional teams.

Aufgaben

• Lead IV, OV, and PV protocols for equipment and processes.
• Manage validation change controls and regulatory documentation.
• Author validation plans and quality records for validated state.
• Investigate validation deviations using root cause analysis.
• Coordinate FAT, SAT, commissioning, and startup activities.

Kenntnisse

GMP compliance

FDA regulations

CSV & validation principles

Project leadership

Root cause analysis

Ausbildung

Bachelor's degree in Engineering/Computer Science

Jobbeschreibung

Piper Companies is seeking a Senior Validation Engineer for an onsite contract in Clayton, NC. The role leads validation activities across automated manufacturing systems in a GMP environment, supporting large-scale pharmaceutical projects, and coordinating cross-functional teams.

The position requires a strong foundation in validation, regulatory compliance, and project leadership, with experience in IV/OV/PV testing and change control processes.