Senior Validation Engineer – Plant of the Future Relocation

Genentech; Holly Springs (MS); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Relocation benefits

Job summary

Genentech is building a state-of-the-art Holly Springs facility and seeks a Principal Validation Engineer to lead qualification activities for equipment and processes. You will drive Equipment Commissioning, Qualification, PV, CV, and tech transfer support in a fast-paced, highly accountable environment.

You will mentor junior staff, collaborate across site and network teams, and ensure compliance with regulatory expectations while advancing a culture of operational excellence and continuous

Qualifications

• Minimum of 8+ years in drug product Process R&D, Engineering, Manufacturing, or Technical Services.
• Pharma/biotech industry experience required.
• Knowledge of cGMP or equivalent regulations.
• Hands-on qualification experience with sterile filling equipment and support systems.
• Strong project management and cross-functional collaboration skills.

Responsibilities

• Develop and manage detailed project and validation plans and timelines.
• 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 manager to ensure new systems are implemented within timelines and financial forecasts.
• Present and justify completed work during audits and Health Authority inspections.
• Procure and manage contractor support for outsourced validation and risk management assignments.
• Support the change management system for new processes, equipment, utilities and facilities.
• Prepare, review and approve relevant sections of regulatory submissions.
• Lead risk assessment sessions and contribute to PQ/CAPAs and product quality systems.

Skills

Project management

Regulatory compliance (cGMP)

Leadership / mentoring

Written and verbal communication

Cross-functional collaboration

Education

BS/MS in chemical/biochemical engineering or related field

Job description

Genentech is building a state-of-the-art Holly Springs facility and seeks a Principal Validation Engineer to lead qualification activities for equipment and processes. You will drive Equipment Commissioning, Qualification, PV, CV, and tech transfer support in a fast-paced, highly accountable environment.

You will mentor junior staff, collaborate across site and network teams, and ensure compliance with regulatory expectations while advancing a culture of operational excellence and continuous