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Process Validation Jobs in New York (NOW HIRING)

Legend Biotech US

Validation Specialist

Raritan, NJ

$120K/yr

Control Aseptic process validation and particle runs from protocol generation, training execution oversite and reporting. Support equipment process qualification and ensure consistency with process ...

Legend Biotech US

Validation Specialist

Raritan, NJ · On-site

$120K/yr

Control Aseptic process validation and particle runs from protocol generation, training execution oversite and reporting. Support equipment process qualification and ensure consistency with process ...

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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 Jul 13, 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 the salary of SoC validation engineer?

The salary of a SoC validation engineer typically ranges from $80,000 to $130,000 annually, depending on experience, location, and company size. Entry-level positions may start lower, while experienced engineers with specialized skills in hardware description languages and verification tools can earn higher salaries.

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 4 types of process validation?

Process validation in the context of process validation involves four main types: prospective validation, concurrent validation, retrospective validation, and revalidation. Prospective validation is performed before a process is in routine production, concurrent validation occurs during initial production runs, retrospective validation reviews historical data to confirm process consistency, and revalidation is conducted when changes are made to the process. These types help ensure that manufacturing processes consistently produce quality products and comply with regulatory standards.

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 does process validation do?

Process validation is a key responsibility in process validation roles, ensuring that manufacturing processes consistently produce products meeting quality standards. It involves designing, testing, and documenting processes to confirm they operate reliably and within specified parameters, often using tools like statistical analysis and validation protocols. This helps maintain product quality, compliance, and reduces the risk of defects or failures.
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
Process Validation & Cleaning Engineer

Process Validation & Cleaning Engineer

Amneal Pharmaceuticals

Piscataway, NJ

$80K - $90K/yr

Full-time

Medical, Retirement

Re-posted 21 hours ago

Amneal Pharmaceuticals rating

7.3

Company rating: 7.3 out of 10

Based on 9 frontline employees who took The Breakroom Quiz

57th of 74 rated pharmaceutical

Job description

Description:

Process Engineer reports to the Manager of Technical Services and plans, executes and functionally directs Process/Cleaning Validation/Study assignments and projects, which require sound pharmaceutical/engineering skills and independent judgment. Works as a team member, educates internal partners on the projects, monitors and executes. Maintains effective and cooperative relationships with all departments within and outside the organization. Managing the post approval projects.


Essential Functions:

  • Prepare validation protocols & reports for manufacturing process and cleaning process qualification, data analysisand prepare reports; execute the manufacturing process and cleaning process qualification/validation/study.
  • Managing the post approval projects. coordinating with cross functional Teams and ensuring the timely completion of projects.
  • Analyzes statistical data, products or functional specifications to determine conformance with standards andestablished quality requirements
  • Coordinate/oversee the development of new processes or troubleshoot existing ones
  • Assist in deviation/investigations to identify root causes and define corrective and/or preventative actions (CAPA) & assist in various audits


Additional Responsibilities:

  • Initiation of Change Controls and Planned Deviations when required

Education:

  • Bachelors Degree (BA/BS) Pharmaceutical/Biomedical Engineering - Required
  • Master Degree (MS/MA) Pharmaceutical/Biomedical Engineering - Preferred

Experience:

  • 2 years or more in Pharmaceutical/Manufacturing Industry

Skills:

  • Excellent verbal and written communication skills - Advanced
  • Proficiency in MS Word/Excel/ PowerPoint/MS project - Advanced

Specialized Knowledge:

  • Basic Analytical Knowledge desirable. In-depth knowledge of manufacturing equipment and processes for Solid Oral, Medical Device, Transdermal, Topical and Liquid Orals.

The base salary for this position ranges from $80,000 to $90,000 per year.   Amneal ranges reflect the Company's good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting.  Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills.  At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement.  We also promote employee well-being with programs that helps you enjoy your career alongside life's many other commitments and opportunities.

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