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Method Validation Jobs in California (NOW HIRING)

Intellectt INC

Supplier Quality Engineer

Irvine, CA · On-site

Develop and execute Test Method Validation protocols (Gage R&R). * Manage engineering change requests (ECRs) in Windchill PLM or similar systems. * Create sampling plans, quality forms, and ...

Bachem

Quality / Validation Engineer

Vista, CA · On-site

$103K - $142K/yr

Write validation protocols and final reports, test methods, standard operating procedures, and technical reports. * Planning, writing, and executing qualification protocols (DQ, IQ, OQ, PQ) and ...

Agilent

Validation Engineer

Carpinteria, CA · On-site

$88K - $137K/yr

The Validation Engineer supports validation and sustaining engineering activities for manufacturing ... Develop and execute Gage R&R studies for test methods and inspection systems * Contribute to ...

Bachem

Quality / Validation Engineer

Vista, CA

$103K - $142K/yr

Write validation protocols and final reports, test methods, standard operating procedures, and technical reports. * Planning, writing, and executing qualification protocols (DQ, IQ, OQ, PQ) and ...

Herbalife

Engineer, Validation

Lake Forest, CA · On-site

Basic experience with equipment cleaning and computer systems validation methodologies is a plus. * Experience in electronic validation systems is preferred but not required. * Openness to learning ...

Supermicro

Application Validation Engineer

San Jose, CA · On-site

$89K - $115K/yr

Expand test methodologies to cover new storage interfaces, protocols, and features. * Testing ... Validate hotplug behavior, PCIe storage devices, and multidrive configurations under various ...

Labcorp

Assay Validation Specialist

Torrance, CA

$25 - $39.38/hr

Monday-Friday 9am-5:30pm This position focuses on assay validation, verification, and laboratory method development. The role supports validation projects from planning through testing to reporting ...

Labcorp

Assay Validation Specialist

Torrance, CA

$25 - $39.38/hr

Monday-Friday 9am-5:30pm This position focuses on assay validation, verification, and laboratory method development. The role supports validation projects from planning throughtesting toreporting ...

Insight Global

Lab Technician

Woodland, CA · On-site

$20/hr

Support computer system validation , method validation, and creation of GMP documentation. Troubleshooting & Problem Solving * Perform root‐cause analysis for nonconformities and resolve ...

Labcorp

Assay Validation Specialist

Torrance, CA · On-site

$25 - $39.38/hr

Monday-Friday 9am-5:30pm This position focuses on assay validation, verification, and laboratory method development. The role supports validation projects from planning through testing to reporting ...

Herbalife

Engineer, Validation

Lake Forest, CA · On-site

Basic experience with equipment cleaning and computer systems validation methodologies is a plus. * Experience in electronic validation systems is preferred but not required. * Openness to learning ...

LanceSoft, Inc.

SerDes Validation Engineer

San Jose, CA · On-site

$52 - $57/hr

SerDes Validation Engineer KEY RESPONSIBILITIES: • Develops characterization and silicon validation plans for high speed transceivers • Defines methodologies for characterization and silicon ...

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All JobsMethod Validation JobsMethod Validation Jobs in California

Method Validation information

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$22

$51

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How much do method validation jobs pay per hour?

As of Jun 15, 2026, the average hourly pay for method validation in California is $51.32, according to ZipRecruiter salary data. Most workers in this role earn between $38.89 and $62.40 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in the Method Validation position, and why are they important?

To excel in Method Validation, a strong background in analytical chemistry, laboratory techniques, and scientific data analysis is typically required, often supported by a degree in chemistry, biochemistry, or a related field. Familiarity with validation protocols, industry regulations (such as GLP, GMP, or ISO standards), and analytical instrumentation (e.g., HPLC, GC, MS) is essential. Strong attention to detail, problem-solving skills, and effective collaboration and documentation abilities help professionals thrive in this position. These skills are vital to ensure that laboratory methods are reliable, regulatory-compliant, and suitable for their intended purposes.

What is a Method Validation job?

A Method Validation job involves assessing and verifying analytical methods to ensure they produce reliable, accurate, and reproducible results. Professionals in this role typically work in pharmaceutical, biotechnology, or chemical industries, following regulatory guidelines such as ICH, USP, or FDA requirements. Their responsibilities include designing validation protocols, performing experiments, analyzing data, and documenting results. Method validation ensures compliance with industry standards and guarantees product quality and safety.

What types of projects or tasks are typically involved in a Method Validation role?

As a Method Validation professional, you will design, conduct, and document experiments to confirm that laboratory methods produce accurate and reproducible results under specified conditions. Typical daily tasks include preparing protocols, running validation samples, analyzing data, and preparing comprehensive validation reports for internal or regulatory review. You’ll work closely with scientists, quality assurance teams, and regulatory specialists to ensure compliance with industry standards. This collaborative environment provides opportunities to contribute to critical product development stages and to build expertise that supports career progression into quality management, regulatory affairs, or advanced analytical roles.

What are the most commonly searched types of Method Validation jobs in California? The most popular types of Method Validation jobs in California are:
What are popular job titles related to Method Validation jobs in California? For Method Validation jobs in California, the most frequently searched job titles are:
What job categories do people searching Method Validation jobs in California look for? The top searched job categories for Method Validation jobs in California are:
Method Validation jobs near you
Associate Director, Analytical Operations / Analytical Operations Director

Associate Director, Analytical Operations / Analytical Operations Director

Cerus

Concord, CA • On-site

Full-time

Medical, Dental, Vision, Life, Retirement

Posted 11 days ago

Job description

About Cerus:
Cerus aims to be the global leader and trusted partner of blood centers and hospitals whose technology, services, and commitment are the lifeblood of safe and accessible blood for patients around the world.
This is a hybrid opportunity where you'll work out of our Concord, CA office twice a week. We are open to both levels Associate Director or Director.
Summary & Scope of Position:
Provide strategic and operational leadership for Analytical Development and Quality Control supporting Cerus' CMC and combination product (drug-device) programs. Responsible for oversight of analytical method lifecycle-including development, qualification, validation, transfer, and ongoing lifecycle management-ensuring compliance with global regulatory expectations and cGMP requirement.
Partner cross-functionally with CMC, Device/Engineering, Quality, and Regulatory Affairs, as well as external CMOs/CDMOs to establish and maintain robust analytical and quality control strategies supporting clinical development through commercialization of Cerus' small molecule and device-based products with select support for biologic/plasma derived components as applicable.
Primary Responsibilities:
  • Lead and oversee the development, validation, transfer, and lifecycle management of analytical methods for drug substances, drug products, device components, raw materials, and intermediates in accordance with ICH/USP/Ph. Eur. Guidelines.
  • Author, review, and approve CMC sections (Module 3) for regulatory submissions, ensuring alignment with global health authority expectations for both drug and device components.
  • Oversee analytical and quality control activities at CMOs/CDMOs, including method transfer, performance monitoring and ensuring compliance with cGMP and quality agreements.
  • Lead and/or support OOS, OOT, deviations, and investigations, driving root cause analysis and effective CAPAs in collaboration with internal teams and external partners.
  • Ensure analytical readiness to support in-process controls, release testing, stability programs, and comparability assessments across clinical and commercial stages.
  • Ensure compliance with cGMP requirements such that products are tested against agreed specifications in timely manner to support in-process, lot release, and stability testing.
  • Ensure phase-appropriate analytical control strategies aligned with regulatory expectations.
  • Evaluate existing analytical method validation packages for accuracy and compliance with current ICH/FDA guidelines.
  • Serve as the analytical SME for change control and CAPA governance, ensuring appropriate impact assessments for both drug and device aspects.
  • Establish and justify product specifications and control strategies using sound statistical principles and risk-based approaches.
  • Oversee development of biological/functional assays to support plasma-derived or lyophilized biologic components, as applicable.
  • Drive continuous improvement initiatives to enhance analytical robustness, efficiency, and compliance across the product lifecycle.

Qualifications/Requirements:
  • M.S. or Ph.D. in Analytical Chemistry, Organic Chemistry, Biochemistry, Life Sciences, or related field with10+ years (Director) or 15+ years (Sr. Director) of relevant industry experience (B.S. with 14+ / 17+ years, respectively).
  • Significant experience in analytical development and CMC support for late stage clinical and commercial programs, preferably including combination products or device related testing.
  • Proven experience with method validation, method transfer, specification setting, and lifecycle management.
  • Experience with technology transfer, process validation, and commercial launch activities.
  • Demonstrated leadership in technical project management, including oversight of external partners (CMOs/CDMOs).
  • Strong working knowledge of cGMP, ICH guidelines, FDA/EMA expectations, and combination product regulatory frameworks.
  • Experience leading or supporting CAPA, change control, and investigations in a regulated environment.
  • Experience with biologic or plasma-derived product analytics is a plus.
  • Excellent communication skills with demonstrated ability to author and review regulatory submissions (CMC sections) and interact with health authorities.
  • Ability to operate strategically and independently in a fast-paced, cross-functional environment.
  • Strong organizational skills and attention to detail, and ability to manage multiple concurrent priorities.
  • Willingness to travel up to 20% domestically and internationally.

We understand that our people are essential to our success. This philosophy is revealed in our competitive benefits package, designed to improve employees' lives both on and off the job.
Benefits plans: medical, dental, vision, domestic partner benefits, paid maternity and paternity leaves, healthcare and dependent care flexible spending, life and accidental death insurance, long-term and short-term disability insurance, matching 401(k), RSUs
Work and family: EAP, legal and financial services, health club membership discounts, tuition reimbursement
Compensation: The base salary range for this position in the selected city is $160,000-$225,000 annually for the Director level. Base pay is one part of the total package to compensate and recognize employees for their work.
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About Cerus

Sourced by ZipRecruiter

Industry

Biotechnology research and development

Company size

201 - 500 Employees

Headquarters location

Concord, CA, US

Year founded

1991

Social media

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