Validation Engineer

Genentech • Oceanside, CA

245d • $80,500 - $149,500 • Onsite

About The Position

Oceanside Operations (OCN) is a drug substance manufacturing organization responsible for the reliable delivery of Roche's commercial portfolio & pipeline products. The Operations organization at OCN is divided into 2 value streams (Stainless Steel and Single use), which combine to produce millions of units of life-saving medicine every year to patients around the world. In this exciting role, you will apply knowledge of qualification and validation principles, manufacturing processes, quality systems, engineering design fundamentals, health authority expectations and industry standards, review and approve qualification and validation documents. You will be responsible for the implementing and maintaining the validated state of the equipment, facility and utility systems, drug substance manufacturing processes, cleaning processes and sanitization/sterilization processes. This is inclusive of tech transfer oversight, projects as well as Make-Assess-Release (MAR) activities. You are also responsible for demonstrating leadership skills and modeling Genentech values and core competencies while working closely with Engineering, MSAT, Quality Assurance and Manufacturing. This position requires strong communication and collaboration skills, the ability to work within teams, facilitate meetings and lead teams. Manage and track the Validation program, including execution and assigned validation projects and ensure target timelines are met and/or issues are communicated / escalated effectively and consistently. Generate, review and approve a variety of Qualification Documents (IQs, OQs, IOQs, PQs, Engineering commissioning and turnover packages, Project Plans and Summary Reports) for equipment, facilities and utilities as well as support Cleaning and Process Validation. Strong understanding of commercial production environment and requirements. Proven ability to make suggestions for improvements as well as ensure programs are operating in a compliant and validated state. Perform role of subject matter expert and assess change control and discrepancy events for validated systems. Participate in cross-functional team meetings and where required, lead/facilitate meetings. Ensure the integration of environmental health, safety, and security into the business processes, systems and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one's functional area. Foster a positive safety culture in which no one gets hurt.

Requirements

• BS degree in Engineering or relevant scientific discipline.
• 4 - 6 years combined engineering/validation experience.
• Minimum of 3 years hands-on experience with equipment/utility/data review and analysis in a batch manufacturing environment within the pharmaceutical/biotechnology industry.
• Understanding of Quality standards, GMPs, Health Authority Regulations, cGMP regulations, Validation practices, and general compliance principles.
• Experience with CHO based manufacturing processes, Delta V automation system, Syncade and electronic Validation Execution.
• Hands-on experience commissioning/validating GMP equipment/utilities preferred.
• Excellent verbal and written communication skills.
• Proven ability to manage multiple activities while maintaining organization.
• Demonstrates initiative, problem anticipation, and familiarity with project management principles.

Responsibilities

• Apply knowledge of qualification and validation principles, manufacturing processes, quality systems, engineering design fundamentals, health authority expectations and industry standards.
• Review and approve qualification and validation documents.
• Implement and maintain the validated state of equipment, facility and utility systems, drug substance manufacturing processes, cleaning processes and sanitization/sterilization processes.
• Oversee tech transfer, projects, and Make-Assess-Release (MAR) activities.
• Demonstrate leadership skills and model Genentech values and core competencies.
• Work closely with Engineering, MSAT, Quality Assurance and Manufacturing.
• Manage and track the Validation program, including execution and assigned validation projects.
• Generate, review and approve Qualification Documents (IQs, OQs, IOQs, PQs, Engineering commissioning and turnover packages, Project Plans and Summary Reports).
• Support Cleaning and Process Validation.
• Assess change control and discrepancy events for validated systems.
• Participate in and lead cross-functional team meetings.
• Integrate environmental health, safety, and security into business processes.
• Report safety and environmental incidents within functional area.

Benefits

• Relocation benefits are available.
• Discretionary annual bonus based on individual and Company performance.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree