Senior Validation Engineer - Drug Product Manufacturing

F. Hoffmann-La Roche AG; Holly Springs (NC); Presencial; USD 95 000 - 176 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Relocation assistance

Resumo da oferta

Genentech in Holly Springs, North Carolina, is seeking a Principal Validation Engineer to lead validation activities for a new state-of-the-art manufacturing plant. You will manage qualification programs for sterilization, filling, and related equipment, while coordinating with cross-functional teams to meet regulatory requirements.

The role requires 8+ years in drug product development or manufacturing, strong project management, and hands-on experience with GMP-compliant validation activities.

Qualificações

• BS/MS in chemical, biochemical engineering or related field with 8+ years of experience in drug product development or manufacturing.
• Experience in pharma/biotech industry is required.
• Knowledge of cGMPs or equivalent regulations.
• Working knowledge of facilities, utilities, filling, packaging, and equipment qualification in a regulated environment; hands-on qualification experience with most sterile filling equipment and support systems.
• Demonstrated project management skills.
• Professional level written and oral communication skills.

Responsabilidades

• Develop and manage detailed project plans, validation plans and timelines for validation activities.
• Author, execute and summarize qualifications for sterilization systems, cleaning systems and filling equipment.
• Prepare change control documentation and summaries for all activities.
• Support project manager ensuring new systems are implemented on time and within budget.
• Present and defend completed work during audits and Health Authority inspections.
• Procure and manage contractor support for outsourced validation and risk management assignments.
• Lead risk assessments and contribute to investigations and change control.
• Mentor junior engineers and maintain state-of-the-art technical expertise.

Conhecimentos

Project management

Validation engineering

Regulatory compliance

cGMP knowledge

Cross-functional collaboration

Leadership

Formação académica

BS/MS in chemical/biochemical engineering

Descrição da oferta de emprego

Genentech in Holly Springs, North Carolina, is seeking a Principal Validation Engineer to lead validation activities for a new state-of-the-art manufacturing plant. You will manage qualification programs for sterilization, filling, and related equipment, while coordinating with cross-functional teams to meet regulatory requirements.

The role requires 8+ years in drug product development or manufacturing, strong project management, and hands-on experience with GMP-compliant validation activities.