Validation Engineer

Validation Engineer – Equipment Validation & Cleaning Validation

Genentech is seeking an experienced Validation Engineer to support its Validation Engineering team at its Oceanside, CA manufacturing facility. This contractor will play a critical role in supporting equipment qualification and cleaning validation activities across both commercial stainless steel and single-use biopharmaceutical manufacturing operations.

The primary focus of this position is Equipment Validation and Cleaning Validation. The successful candidate will have extensive hands-on experience developing, authoring, executing, and documenting validation protocols within a highly regulated cGMP biopharmaceutical or biotechnology manufacturing environment.

This individual will work directly with manufacturing, engineering, quality, and other cross-functional teams to ensure manufacturing equipment and cleaning processes meet established performance, quality, and regulatory requirements.

This is a hands-on technical role for someone who can independently manage validation activities from protocol development through execution, troubleshooting, results evaluation, and final documentation.

Key Responsibilities

1. Equipment Qualification & Validation

• Author, review, and execute equipment qualification protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Perform equipment qualification and validation activities for GMP manufacturing systems.
• Support validation of biopharmaceutical manufacturing equipment, including:
• Bioreactors.
• Chromatography skids.
• Tangential Flow Filtration (TFF) systems.
• Autoclaves.
• Stainless steel manufacturing equipment.
• Single-use manufacturing systems and equipment.
• Verify that equipment and systems operate according to approved specifications and established acceptance criteria.
• Review equipment documentation, testing results, and qualification records.
• Identify and troubleshoot equipment qualification discrepancies and execution issues.
• Ensure equipment is appropriately qualified and documented before being released for manufacturing use.

2. Cleaning Validation & Cleaning Verification

• Develop, author, review, and execute Cleaning Validation (CV) and cleaning verification protocols.
• Support cleaning validation activities for commercial stainless steel manufacturing equipment and single-use manufacturing operations.
• Demonstrate hands-on knowledge of Clean-in-Place (CIP) and Steam-in-Place (SIP) systems.
• Develop and execute cleaning validation sampling plans.
• Perform and document visual inspections and cleaning verification activities.
• Coordinate and evaluate analytical testing results, including:
• Total Organic Carbon (TOC).
• Conductivity.
• Bioburden.
• Endotoxin.
• Support residue limit assessments and cleaning recovery studies.
• Evaluate cleaning validation data against established acceptance criteria.
• Investigate cleaning validation discrepancies and support resolution of technical issues.
• Ensure cleaning processes consistently meet established GMP and quality requirements.

3. Protocol Development, Execution & Documentation

• Independently develop and author technical validation protocols and supporting documentation.
• Execute validation protocols in accordance with approved procedures and project timelines.
• Evaluate test results and determine whether acceptance criteria have been met.
• Identify, investigate, and resolve protocol execution discrepancies.
• Author protocol exceptions and work with cross-functional stakeholders to document and resolve issues.
• Prepare validation summaries and final reports.
• Maintain accurate, complete, and traceable validation documentation.
• Support continuous improvement initiatives related to validation processes and documentation.

4. Regulatory Compliance & GMP Standards

• Ensure all validation activities comply with current cGMP requirements and applicable industry and regulatory standards.
• Follow Roche/Genentech quality standards, procedures, and documentation requirements.
• Maintain strong documentation practices and ensure validation records are accurate, complete, and audit-ready.
• Collaborate with Quality Assurance, Manufacturing, Engineering, and other departments to support compliant manufacturing operations.

Required Qualifications

Education

• Bachelor’s or Master’s degree in one of the following disciplines:
• Chemical Engineering.
• Biomedical Engineering.
• Mechanical Engineering.
• Biochemistry.
• Related technical or engineering discipline.

Professional Experience

• 8–10+ years of direct Validation Engineering experience within a cGMP biopharmaceutical or biotechnology manufacturing facility.
• Extensive hands-on experience authoring and executing equipment qualification protocols (IQ/OQ/PQ).
• Direct experience with Cleaning Validation and cleaning verification activities.
• Demonstrated experience supporting commercial biopharmaceutical manufacturing operations.
• Experience working with both stainless steel and single-use manufacturing equipment.
• Ability to independently manage validation projects, timelines, protocol execution, and documentation.

Required Technical Experience

Candidates must demonstrate hands-on experience in BOTH areas:

Equipment Validation:

• IQ/OQ/PQ protocol development and execution.
• Bioreactors.
• Chromatography skids.
• TFF systems.
• Autoclaves.
• GMP manufacturing equipment qualification.

Cleaning Validation:

• Cleaning Validation (CV) protocol development and execution.
• Cleaning verification.
• CIP/SIP systems.
• Sampling plans and visual inspections.
• Residue limits and recovery studies.
• Analytical testing coordination, including TOC, conductivity, bioburden, and endotoxin.

Soft Skills

• Excellent technical writing and documentation skills.
• Strong verbal and written communication.
• Ability to work independently with minimal supervision.
• Strong troubleshooting and problem-solving capabilities.
• Effective cross-functional collaboration.
• Ability to manage multiple validation activities and meet established deadlines.

Work Authorization Requirements

• Must be a U.S. citizen or lawful permanent resident (Green Card holder).
• Must be able to work onsite at the Oceanside, CA manufacturing facility five days per week.

Work Schedule & Location

• Location: Oceanside, CA.
• Work Arrangement: 100% onsite.
• Days: Monday–Friday.
• Hours: 9:00 AM–5:30 PM Pacific Time.
• Contract opportunity.

Interview Process

Round 1 – Hiring Manager Interview

• Format: Virtual.
• Duration: Approximately 30 minutes.
• Focus: Technical background, relevant validation experience, communication skills, and overall alignment with the position.

Round 2 – Panel Interview

• Format: Onsite at the Genentech Oceanside facility.
• Duration: Approximately 1 hour.
• Focus: In-depth technical evaluation, hands-on equipment validation and cleaning validation experience, problem-solving, and cross-functional collaboration.

Candidates must be comfortable participating in both interview rounds, including traveling onsite to Oceanside for the second-round panel interview.

Ideal Candidate Profile

The ideal candidate is a senior-level Validation Engineer coming directly from a pharmaceutical, biotechnology, or biopharmaceutical manufacturing environment. They should be capable of independently authoring and executing both equipment qualification and cleaning validation protocols, with strong practical experience in CIP/SIP systems, GMP manufacturing equipment, and validation documentation.

The strongest candidates will have