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Computer System Validation Engineer Jobs in New York

Apex Informatics

Validation Tester

Farmingdale, NY · On-site

... Computer Systems Validation (CSV) • Deep understanding of FDA regulations, GxP requirements, and data integrity • Experience supporting FDA approval processes and regulatory submissions • ...

voyant

Engineer, Validation

Holmdel, NJ

This role serves as the subject matter expert (SME) for hygiene systems and validation, driving ... The Engineer, Validation Technical partners closely with Engineering, Quality Assurance, and ...

Voyant Beauty

Engineer, Validation

Holmdel, NJ · On-site

This role serves as the subject matter expert (SME) for hygiene systems and validation, driving ... The Engineer, Validation Technical partners closely with Engineering, Quality Assurance, and ...

ZT Systems

Validation Lab Manager

Secaucus, NJ · On-site

$124K - $182K/yr

... supporting ZT System's Validation Engineering group on several projects in various stages of ... Experience within a computer hardware environment is preferred. * Fundamental understanding of ...

ZT Systems

Validation Lab Manager

Secaucus, NJ

$124K - $182K/yr

... supporting ZT System's Validation Engineering group on several projects in various stages of ... Experience within a computer hardware environment is preferred. * Fundamental understanding of ...

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Computer System Validation Engineer information

See New York salary details

$32

$56

$82

How much do computer system validation engineer jobs pay per hour?

As of Jun 13, 2026, the average hourly pay for computer system validation engineer in New York is $56.67, according to ZipRecruiter salary data. Most workers in this role earn between $42.60 and $70.48 per hour, depending on experience, location, and employer.

Is CSV a skill?

In the context of a Computer System Validation Engineer, knowledge of CSV typically refers to Computer System Validation processes rather than a specific skill. However, familiarity with validation protocols, documentation, and related tools is essential for the role. Proficiency in using validation software and understanding regulatory requirements are valuable skills for CSV professionals.

What are some common challenges faced by Computer System Validation Engineers in regulated industries?

Computer System Validation Engineers often encounter challenges such as keeping up with evolving regulatory requirements, managing documentation for multiple systems, and ensuring timely validation while coordinating with cross-functional teams. Balancing strict compliance with project deadlines can be demanding, especially when systems are complex or legacy infrastructure is involved. Additionally, effective communication with IT, QA, and business stakeholders is essential to address issues quickly and maintain validation standards.

What does a computer system validation engineer do?

A computer system validation engineer ensures that computer systems used in regulated industries, such as pharmaceuticals or biotech, meet required standards for quality and compliance. They develop validation protocols, execute testing, document results, and maintain validation documentation to verify systems function correctly and consistently. This role often involves working with validation tools, regulatory guidelines, and quality assurance processes.

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

To thrive as a Computer System Validation Engineer, you need a solid background in computer science or engineering, knowledge of regulatory requirements (such as FDA or GxP), and experience in validation processes. Familiarity with validation tools, quality management systems, and documentation software is typically required, along with certifications like ISPE or ASQ being beneficial. Strong attention to detail, analytical thinking, and effective communication are essential soft skills for coordinating teams and ensuring compliance. These skills and qualities are crucial to ensure that computer systems meet regulatory standards, maintain data integrity, and support business operations in regulated industries.

What is the difference between Computer System Validation Engineer vs Quality Assurance Specialist?

AspectComputer System Validation EngineerQuality Assurance Specialist
CertificationsGAMP, GxP validation certificationsISO, Six Sigma, GMP certifications
Work EnvironmentPharmaceutical, biotech, medical device industriesManufacturing, software, healthcare sectors
Primary FocusValidating computer systems and software complianceEnsuring overall quality and process improvements

The Computer System Validation Engineer primarily focuses on validating computer systems to meet regulatory standards, ensuring software compliance in regulated industries. In contrast, the Quality Assurance Specialist oversees broader quality processes, including audits and process improvements. Both roles require knowledge of industry regulations but differ in scope and specific responsibilities.

What is the salary of computer system validation?

The salary of a Computer System Validation Engineer typically ranges from $70,000 to $120,000 annually, depending on experience, location, and industry. Professionals with certifications like GAMP or experience with validation tools may command higher salaries, especially in regulated environments such as pharmaceuticals or biotech.

What engineers make $500,000?

Highly experienced computer system validation engineers working in the pharmaceutical or biotech industries, especially those with advanced certifications and specialized skills, can reach or exceed a $500,000 annual salary. Such roles often require extensive expertise, leadership responsibilities, and sometimes involve consulting or management positions. Salaries at this level are typically seen in senior or executive roles within large organizations or specialized consulting firms.
What are popular job titles related to Computer System Validation Engineer jobs in New York? For Computer System Validation Engineer jobs in New York, the most frequently searched job titles are:
What job categories do people searching Computer System Validation Engineer jobs in New York look for? The top searched job categories for Computer System Validation Engineer jobs in New York are:
Computer System Validation Engineer jobs near you

Senior Manager IT Quality Assurance Validation Computerization Systems

Lynkx Staffing LLC

Saddle Brook, NJ • On-site

Full-time

Posted 10 days ago

Job description

Senior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving.
  • Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements.
  • Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments.
  • Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements.
  • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications.
  • Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports.
  • Coordinate implementation validation/qualification strategies and serve as the subject matter expert.
  • Present project status reports to management as well as project teams.
  • Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes.
  • Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements.
  • Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report.
  • Support internal, client, and regulatory audits and inspections.
  • Generate or review/update computer system related policies, procedures, templates, forms, etc.
  • Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP’s regulations, GAMP, industry standards, policies and procedures.
  • Performs other quality system related duties as necessary.
REQUIREMENTS
  • BA/BS Degree in a Scientific or Engineering discipline
  • 8 + years experience computerized system experience with IT compliance/validation/qualification activities.
  • 8 + years experience working in an FDA-regulated, GxP-related environment.
  • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance.
  • Comprehensive knowledge in Software Validation and Data Integrity Principles.
  • Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations.
  • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models.
  • Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems.
  • Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ).
  • Knowledge of Software Risk Management Principles and tools.
  • Knowledge and proven ability working with Risk Management methodologies and tools.
  • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus.
  • Experience with application system validation and infrastructure qualification.
  • Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus.
  • Experience with writing and approving Standard Operating Procedures and Quality Standards.
  • Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint).
  • Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams.
  • Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers.
  • Solid organizational and time management skills, proven project management, presentation and facilitation skills.
  • Innovation and strategic compliance skills including looking internally and externally for best practices.
  • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems.
  • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities.
  • The ability to enable and drive change while being focused on internal and external customers.
  • Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines.
  • Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise.
  • 10% travel required.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.