Senior Validation Engineer — Pharma Plant of the Future

Genentech; Holly Springs (NC); On-site; USD 95,000 - 176,000; Full time

Benefits offered by this job

Relocation benefits

Job summary

Genentech in Holly Springs, NC is seeking a Principal Validation Engineer to lead Equipment Commissioning, Qualification, and Validation activities for a new plant. You will drive technology transfer, risk management and regulatory submissions with a focus on process validation.

You will mentor junior engineers, collaborate across site networks, and maintain cutting-edge knowledge of industry best practices to sustain a high-performance culture. Relocation benefits are available for this role.

Qualifications

• BS/MS in chemical, biochemical engineering or a related field with 8+ years of experience in drug product R&D, engineering, manufacturing or technical services.
• Experience in the pharma/biotech industry is required.
• Knowledge of cGMPs or equivalent regulations.
• Hands-on qualification experience with sterile filling equipment and support systems.
• Strong project management skills and ability to work with internal teams, partners, suppliers and customers.
• Excellent written and oral communication skills.

Responsibilities

• Develop and manage the detailed project plans, validation plans and timelines for validation activities.
• Author, execute and summarize qualifications for sterilization systems, cleaning systems, filling equipment and supporting equipment.
• Prepare change control documentation, including protocols and summary reports.
• Support project management to ensure new systems are implemented within timelines and forecasts.
• Present rationale for completed work during periodic audits and Health Authority inspections.
• Mentor junior validation engineers and train staff on practices and procedures.
• Collaborate with site and network teams to ensure seamless integration of processes.
• Lead and facilitate Risk Assessment sessions and support investigations.

Skills

Project management

Communication

Team collaboration

Operational excellence

Education

BS/MS in chemical, biochemical engineering, or related field/experience

Job description

Genentech in Holly Springs, NC is seeking a Principal Validation Engineer to lead Equipment Commissioning, Qualification, and Validation activities for a new plant. You will drive technology transfer, risk management and regulatory submissions with a focus on process validation.

You will mentor junior engineers, collaborate across site networks, and maintain cutting-edge knowledge of industry best practices to sustain a high-performance culture. Relocation benefits are available for this role.