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Process Validation Jobs in New York (NOW HIRING)

CompoSecure

Lead Process Engineer

Somerset, NJ · On-site

$109K - $142K/yr

Oversee and coordinate new product introduction (NPI) activities, including process validation, work instruction development, and ramp-up readiness. * Collaborate with Quality, Maintenance, and ...

CompoSecure

Lead Process Engineer

Somerset, NJ · On-site

$139K - $225K/yr

Oversee and coordinate new product introduction (NPI) activities, including process validation, work instruction development, and ramp-up readiness. * Collaborate with Quality, Maintenance, and ...

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Process Validation information

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$8

$43

$75

How much do process validation jobs pay per hour?

As of Aug 21, 2026, the average hourly pay for process validation in New York is $43.25, according to ZipRecruiter salary data. Most workers in this role earn between $25.24 and $56.30 per hour, depending on experience, location, and employer.

What is process validation?

Process validation is a documented procedure used in industries, especially pharmaceuticals and manufacturing, to ensure that a process consistently produces a product meeting its predetermined specifications and quality attributes. It involves planning, conducting, and analyzing studies that provide evidence the process is reliable and reproducible. Regulatory agencies like the FDA require process validation to guarantee product safety and efficacy. Process validation typically includes design, qualification, and continued monitoring stages. This ensures that any variations in the process do not affect the final product's quality.

What are some common challenges faced by professionals in process validation, and how can they be addressed?

Professionals in Process Validation often encounter challenges such as managing tight project timelines, ensuring compliance with evolving regulatory standards, and resolving unexpected deviations during validation runs. Effective communication with cross-functional teams—such as Quality Assurance, Manufacturing, and R&D—can help address these issues quickly. Staying proactive with documentation, maintaining a robust risk assessment process, and continually updating knowledge on industry regulations are key strategies to overcoming these challenges and ensuring successful validation outcomes.

What are the key skills and qualifications needed to thrive as a process validation specialist, and why are they important?

To thrive as a Process Validation Specialist, you need a strong background in engineering, life sciences, or a related field, along with expertise in validation protocols and regulatory guidelines such as GMP. Familiarity with validation software, data analysis tools, and documentation systems like LIMS is typically required, and certifications such as Six Sigma or ASQ may be advantageous. Attention to detail, analytical thinking, and effective communication are crucial soft skills for this role. These skills ensure that manufacturing processes consistently produce products that meet quality standards and regulatory compliance, which is essential for patient safety and product efficacy.

What is the difference between Process Validation vs Quality Assurance Specialist?

AspectProcess ValidationQuality Assurance Specialist
CredentialsGMP, ISO certifications, technical trainingGMP, ISO certifications, auditing training
Work EnvironmentManufacturing, pharmaceutical, biotech facilitiesQuality departments, manufacturing sites
Employer & Industry UsageUsed in regulated industries to ensure process consistencyEnsures product quality through audits and compliance

Process Validation focuses on confirming that manufacturing processes consistently produce quality products, while Quality Assurance Specialists oversee overall quality systems, audits, and compliance. Both roles are essential in regulated industries but serve different functions in maintaining product integrity.

What skills are needed for process validation?

Process validation professionals need strong analytical skills, attention to detail, and knowledge of manufacturing processes and quality systems. Familiarity with regulatory requirements such as GMP, validation protocols, and proficiency with data analysis tools are also important. Effective communication and documentation skills are essential for ensuring compliance and successful validation activities.

What are popular job titles related to Process Validation jobs in New York?

For Process Validation jobs in New York, the most frequently searched job titles are:

What job categories do people searching Process Validation jobs in New York look for?

The top searched job categories for Process Validation jobs in New York are:

Process Validation jobs near you
Infographic showing various Process Validation job openings in New York as of August 2026, with employment types broken down into 1% As Needed, 78% Full Time, 17% Part Time, 3% Contract, and 1% Nights. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $89,970 per year, or $43.3 per hour.

Senior Quality Validation Specialist

Cellares

Bridgewater, NJ • On-site

$90K - $210K/yr

Full-time

Medical, Dental, Vision, Retirement

Re-posted 26 days ago

Job description

We are seeking an innovative and highly motivated Senior Quality Validation Specialist, who will contribute significantly to the growth of the Cellares team.
The Quality Validation team at our IDMO Bridgewater facility will be responsible for providing Quality Assurance oversight of environmental, equipment (analytical and production), facility & utility, site automation, process validation & engineering documents, test protocols, CAPAs, deviations, change control records, and additional site based technical documentation and activities. This individual will work closely with cross-functional teams to maintain high standards of quality in a regulated environment.
Candidates should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.
Responsibilities
  • Review and approve complex documentation in support of GMP operations at the IDMO, including but not limited to facility plans, validation, CSV and other technical protocols and reports, trend reports, risk assessments, standard operating procedures, CAPAs, deviations, etc.
  • Author and maintain the IDMO Site Validation Plan
  • Provide Quality oversight of process validation studies and process performance qualifications
  • Provide oversight of cleanroom lifecycle programs including aseptic process simulations, environmental monitoring performance qualification, cleanroom certification & recertification, cleaning & sanitization, and facility controls
  • Proactively identify & resolve technical and compliance issues/gaps
  • Provide support to multiple areas within and, potentially, between facilities, requiring a high level of regulatory, Quality System, facility, equipment and process knowledge
  • Ensure adherence to internal procedures and industry/regulatory expectations related to facility/equipment controls and release before, during and after production operations (i.e. routine operations - calibration/maintenance, shutdowns, construction projects, etc.)
  • Collaborate with stakeholders within and outside of the IDMO Facility, and communicate equipment, facility and system status; monitor progress and issue status reports
  • Act as Quality Engineering Subject Matter Expert for responsible areas/projects during client or regulatory inspections
  • Drive continuous improvement and increase efficiency and productivity

Requirements
  • Bachelor's degree in a scientific or engineering discipline
  • 5 to 8 years of experience in a GMP environment in pharmaceutical, biologics, vaccines, cell or gene therapy operations, including solid experience in Quality Systems and Regulatory CMC
  • 2+ years of direct experience in quality or validation, and demonstrated knowledge of relevant cGMP regulations
  • Excellent knowledge of the regulations for biologics, cell and gene therapy products
  • Strong knowledge of current Good Manufacturing Practices (GMP); experience with on-site regulatory inspections is desirable
  • Comprehensive knowledge of global GMP and regulatory requirements for biotechnology, cell and gene therapy products and Quality by Design approaches
  • Excellent understanding of risk management and CAPA processes
  • Ability to understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy
  • Experience with computerized systems validation (CSV) is a plus.

$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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