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Validation Engineer I Jobs (NOW HIRING)

SCA Pharma

Validation Engineer

Windsor, CT · On-site

The Validation Engineer oversees the aseptic process simulations (media fills), equipment ... Ensure that C&Q and Validation project deliverables (i.e., Specification, SOPs; Protocols/Reports;

Agilent

Validation Engineer

Frederick, CO · On-site

Execute validation studies in support of engineering, manufacturing, process development ... i.e. worst-case soil studies). * Support Manufacturing, Engineering, Quality Assurance (QA), and ...

Socket.dev

Validation Engineer

Windsor, CT · On-site

$95 - $140/hr

The Validation Engineer oversees the aseptic process simulations (media fills), equipment ... Ensure that C&Q and Validation project deliverables (i.e., Specification, SOPs; Protocols/Reports;

New

Leiters Inc

Validation Engineer

Buena, NJ · On-site

$97K - $121K/yr

Bachelor's degree in a STEM field required; i.e. engineering, chemistry, or relevant industry experience. * 4+ years of validation experience, preferably in a highly regulated environment.

New

SCA Pharma

Validation Engineer

Windsor, CT · On-site

The Validation Engineer oversees the aseptic process simulations (media fills), equipment ... Ensure that C&Q and Validation project deliverables (i.e., Specification, SOPs; Protocols/Reports;

ClinDCast LLC

Silicon Validation Engineer

San Jose, CA · On-site

$35 - $40/hr

We are looking for a Silicon Validation Engineer with experience in hardware validation and board ... Perform electrical measurements on various I/O interfaces such as PCIe, USB, HDMI, I2C, and SPI.

Leiters Inc

Bachelor's degree in a STEM field required; i.e. engineering, chemistry, or relevant industry experience. * 4+ years of validation experience, preferably in a highly regulated environment.

New

ClinDCast LLC

Silicon Validation Engineer

Santa Clara, CA · On-site

$120 - $160/hr

We are looking for a Silicon Validation Engineer with experience in hardware validation and board ... Perform electrical measurements on various I/O interfaces such as PCIe, USB, HDMI, I2C, and SPI.

Socket.dev

Silicon Validation Engineer

Santa Clara, CA · On-site

$110 - $150/hr

We are looking for a Silicon Validation Engineer with experience in hardware validation and board ... Perform electrical measurements on various I/O interfaces such as PCIe, USB, HDMI, I2C, and SPI.

New

Fujirebio Europe

WI · On-site

$70 - $90/hr

Als Process & Validation Engineer speel je een sleutelrol in het ontwikkelen en valideren van ... Engineer, i.g.v. equipment / uitilities. * Je documenteert alle relevante project‑ en ...

New

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Validation Engineer I information

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How much do validation engineer i jobs pay per hour?

As of Aug 21, 2026, the average hourly pay for validation engineer i in the United States is $52.00, according to ZipRecruiter salary data. Most workers in this role earn between $39.42 and $63.22 per hour, depending on experience, location, and employer.

What is a Validation Engineer I?

A Validation Engineer I is an entry-level professional responsible for ensuring that systems, equipment, or processes meet regulatory standards and function as intended. They typically work in industries like pharmaceuticals, biotechnology, medical devices, or manufacturing, performing tasks such as creating validation protocols, executing tests, and documenting results. Their work helps maintain product quality and compliance with industry regulations. Validation Engineer I roles often involve collaboration with quality assurance and production teams. This position is ideal for those with a background in engineering or science seeking to start a career in quality and compliance.

What are some common challenges faced by a Validation Engineer I during project execution?

As a Validation Engineer I, one common challenge is managing tight project timelines while ensuring all validation protocols and documentation meet regulatory standards. New engineers often need to quickly familiarize themselves with complex equipment, processes, and compliance requirements specific to the industry, such as FDA or ISO guidelines. Collaboration with cross-functional teams, such as manufacturing, quality assurance, and R&D, is essential to troubleshoot issues and ensure smooth validation processes. Developing effective communication skills and attention to detail will help you overcome these challenges and contribute positively to project success.

What are the key skills and qualifications needed to thrive as a Validation Engineer I, and why are they important?

To succeed as a Validation Engineer I, you typically need a bachelor's degree in engineering or a related field and a solid understanding of validation protocols and industry regulations. Familiarity with technical tools such as validation management software, data analysis programs, and documentation systems is common, as well as knowledge of GMP standards. Attention to detail, problem-solving abilities, and strong teamwork and communication skills help set top performers apart. These competencies are vital to ensure that processes and equipment meet regulatory requirements and function reliably within quality-driven industries.

What is the difference between Validation Engineer I vs Validation Engineer II?

AspectValidation Engineer IValidation Engineer II
Required CredentialsBachelor's in Engineering, Life Sciences, or related field; often entry-level certificationsSame as Validation Engineer I, with additional experience or certifications
Work EnvironmentManufacturing, pharmaceutical, or biotech facilities; supervised tasksMore independent responsibilities; oversight of validation processes
Employer & Industry UsageCommonly employed in regulated industries like pharma and biotechProgression role within the same industries
Search & Comparison IntentEntry-level validation roles; understanding career progressionMid-level validation roles; seeking advancement opportunities

The main difference between Validation Engineer I and Validation Engineer II lies in experience and responsibility. Validation Engineer II typically has more hands-on experience, handles more complex validation tasks, and may oversee Validation Engineer I activities. Both roles require similar educational backgrounds and certifications, but Validation Engineer II often involves greater independence and technical expertise.

Are validation engineers in demand?

Validation engineers are in demand across industries such as pharmaceuticals, biotechnology, and manufacturing, where regulatory compliance and quality assurance are critical. They often require knowledge of validation protocols, industry standards, and tools like GxP and risk management, making their skills valuable in regulated environments.

Do validation engineers make good money?

Validation engineers typically earn competitive salaries that vary by industry, experience, and location. Entry-level validation engineers can expect to start around $60,000 to $80,000 annually, with experienced professionals earning over $100,000, especially in regulated sectors like pharmaceuticals or biotech. Skills in validation protocols, regulatory compliance, and tools like GxP are valuable for higher compensation.
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Validation Engineer I jobs near you
Infographic showing various Validation Engineer I job openings in the United States as of August 2026, with employment types broken down into 94% Full Time, 2% Part Time, and 4% Contract. Highlights an 85% Physical, 6% Hybrid, and 9% Remote job distribution, with an average salary of $108,152 per year, or $52 per hour.

Senior Validation Engineer (I, II, III)

Cellares

Bridgewater, NJ • On-site

$90K - $210K/yr

Full-time

Medical, Dental, Vision, Retirement

Re-posted 24 days ago

Job description

We are seeking a Senior Validation Engineer with solid hands-on validation experience and a collaborative mindset to help drive validation harmonization across the Cellares global landscape.
The primary focus of this position will be responsible for execution activities for QC and Manufacturing equipment. In addition to many of the equipment seen at traditional cell & gene therapy facilities, this position will focus on the qualification and validation of several Cellares proprietary equipment. The ideal candidate for this position will have not only a deep understanding of qualification and validation lifecycle activities across all manufacturing process streams, but also have the ability to apply that knowledge base to the Cellares Cell Shuttle and Cell Q. In addition to equipment qualification and validation, the person in this position will also execute facilities and utility systems. The desired candidate will be very hands-on with execution, but also develop documentation; validation/qualification protocols (IQ/OQ/PQ), risk assessments, system impact assessments, summary reports, SOPs and other technical documents. This position, at times, will require the oversight of contract workers, junior level engineers and equipment vendors.
Candidates should enjoy working in a fast-paced, mission-driven environment, be comfortable with using justified risk based approaches, and be prepared to tackle a broad selection of challenges as the company grows.
Responsibilities
  • Generate and develop qualification and validation lifecycle documents, templates, protocols, reports including but not limited to the following: SOPs related to the commissioning, qualification and validation programs, Risk Assessments, System Impact Assessments, Validation Master Plans, URS, project plans, Validation Master Lists
  • Review validation protocols, executed validation studies, and validation summary reports as needed to support GMP manufacturing and laboratory systems
  • Ensure maintenance of validated status via Periodic Review (PR) and requalification activities
  • Knowledge of CSV methodology and required lifecycle document content including risk-based approaches used to validate technical systems
  • Knowledge of Data Integrity and ALCOA+ principles and the applicability to process and analytical systems
  • Knowledge of QC equipment validation as it relates to the interface of IOQ and method validation
  • Support vendor qualification activities including risk assessments and participate in selection of vendors that support validation effort
  • Support the change control program with respect to facility, equipment, and utility validation changes
  • Evaluate validation impact of equipment introduction/upgrades and software/hardware changes
  • Follow written SOPs, and ensure SOP training remains current
  • Oversee contractors who carry out commissioning, qualification and validation projects related to Facility, Utility, and Equipment
  • Provide guidance on topics to foster a quality culture and quality mindset
  • Actively participate in continuous improvement activities with cross-functional teams
  • Provide status updates to stakeholders and internal customers of validation activities in their respective areas
  • Identify qualification/validation gaps, strategize on solutions, drive gap mitigation
  • Mentoring and training junior level engineers
  • Foster collaborative approach to ensure harmonization of qualification/validation approach across all Cellares sites
  • Participate in regulatory inspections

Requirements
  • Minimum of a Bachelor's degree in Engineering or a scientific related field and 8 years of experience working in a GMP regulated environment
  • Minimum of 5 years qualification and validation hands on experience
  • Detailed knowledge of 21 CFR Part 210,211, Device GMPs (21 CFR Part 820), EU GMPs (Annex 1) requirements
  • Knowledge of System Development Life Cycle concepts and software (GAMP5 expected pharmaceutical standards, 21 CFR Part 11)
  • Excellent technical writing skills with an understanding of good documentation practice
  • Self-motivated, detail-oriented and passionate about advancing the field of cell therapies
  • Collaborative, solution oriented, comfortable in an agile environment

$90,000 - $210,000 a year
Cellares total compensation package contains competitive base salaries, highly subsidized Medical, Dental, and Vision Plans, 401(k) Matching, Onsite lunches, and Stock options. All displayed pay ranges are approximate, negotiable, and location dependent.
This is Cellares
Cellares is the first Integrated Development and Manufacturing Organization (IDMO) and takes an Industry 4.0 approach to mass manufacturing the living drugs of the 21st century. The company is both developing and operating integrated technologies for cell therapy manufacturing to accelerate access to life-saving cell therapies. The company's Cell Shuttle integrates all the technologies required for the entire manufacturing process in a flexible and high-throughput platform that delivers true walk-away, end-to-end automation. Cell Shuttles will be deployed in Cellares' Smart Factories around the world to meet total patient demand for cell therapies at global scale. Partnering with Cellares enables academics, biotechs, and pharma companies to accelerate drug development and scale out manufacturing, lower process failure rates, lower manufacturing costs, and meet global patient demand.
The company is headquartered in South San Francisco, California with its commercial-scale IDMO Smart Factory in Bridgewater, New Jersey. The company is backed by world-class investors and has raised over $355 million in financing.
Leveling will be based on overall experience, education, and demonstration of knowledge throughout the interview process.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
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About Cellares

Sourced by ZipRecruiter

Industry

Pharmaceutical and medicine manufacturing

Company size

11 - 50 Employees

Headquarters location

South San Francisco, CA, US

Year founded

2019

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