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Process Validation Jobs in New York (NOW HIRING)

Lead or support new product introduction (NPI) activities, including process validation, work instruction development, and ramp-up readiness. * Collaborate with cross-functional teams (Quality ...

Process Engineer 1st Shift

Somerset, NJ · On-site

$84K - $110K/yr

Lead or support new product introduction (NPI) activities, including process validation, work instruction development, and ramp-up readiness. * Collaborate with cross-functional teams (Quality ...

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Process Validation information

See New York salary details

$8

$43

$75

How much do process validation jobs pay per hour?

As of Aug 5, 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 documentation practices is essential. Proficiency with data analysis tools and good communication skills are also important for successful validation activities.
Infographic showing various Process Validation job openings in New York as of July 2026, with employment types broken down into 1% As Needed, 80% Full Time, 15% Part Time, 1% Temporary, and 3% Contract. Highlights an 93% Physical, 2% Hybrid, and 5% Remote job distribution, with an average salary of $89,970 per year, or $43.3 per hour.

Process Validation & Cleaning Engineer

Amneal Pharmaceuticals

Piscataway, NJ • On-site

$80K - $90K/yr

Full-time

Medical, Retirement

Re-posted 23 days ago


Amneal Pharmaceuticals rating

6.7

Company rating: 6.7 out of 10

Based on 12 frontline employees who took The Breakroom Quiz

74th of 86 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

Qualifications
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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