Validation Engineer – Equipment Validation & Cleaning Validation

Position Overview

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 a combination of:

• 8–10+ years of direct biopharmaceutical validation experience.

• Strong equipment qualification (IQ/OQ/PQ) background.

• Extensive Cleaning Validation experience.

• Hands-on CIP/SIP experience.

• Experience with stainless steel and single-use manufacturing facilities.

• Ability to independently manage validation activities from start to finish.

Nesco Resource offers a comprehensive benefits package for our associates, which includes a MEC (Minimum Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services.

Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.