Validation Engineer

Genentech

1d • Onsite

About The Position

Oceanside Operations (OCN) is a drug substance manufacturing organization dedicated to the reliable production of Roche’s commercial portfolio and pipeline products. Every year, OCN delivers millions of units of life-saving medicines to patients around the globe by leveraging its two integrated value streams: Stainless Steel and Single-Use production systems.
As a Validation Engineer at OCN, you will play a critical role in ensuring that equipment, facilities, utilities, manufacturing processes, and cleaning/sanitization systems meet rigorous qualification and validation standards. Drawing from your expertise in qualification principles, engineering design fundamentals, manufacturing processes, and health authority expectations, you will review and approve validation documents, oversee tech transfers, and support Make-Assess-Release (MAR) activities.
Beyond technical expertise, you will model Genentech’s values and core competencies, showcasing strong leadership, communication, and collaboration skills. In this role, you will work closely with cross-functional teams, including Engineering, MSAT, Quality Assurance, and Manufacturing, facilitating meetings and driving impactful projects. This is an opportunity to make a meaningful contribution to delivering essential therapies to patients worldwide.

Requirements

• BS degree in Engineering or relevant scientific discipline.
• 4 - 6 years combined engineering/validation experience with a minimum of 3 years hands-on experience with equipment / utility / data review and analysis in a batch manufacturing environment within the pharmaceutical / biotechnology industry.
• Quality and Regulatory Knowledge: Must understand Quality standards, GMPs, Health Authority Regulations, cGMP regulations, Validation practices, and general compliance principles.
• Technical and System Expertise: Experience with CHO based manufacturing processes, Delta V automation system, Syncade and electronic Validation Execution. Hands-on experience commissioning/validating GMP equipment/utilities preferred.
• Communication Skills: Excellent verbal and written communication skills, and proven ability to manage multiple activities while maintaining organization.
• Teamwork and Initiative: Demonstrates initiative, problem anticipation, familiarity with project management principles, ability to work effectively in customer service/business partner roles, and strong collaboration skills with staff at all levels.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level