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Software Validation Jobs in New Jersey (NOW HIRING)

Cloud think technologies LLC

MES Engineer

Raritan, NJ · On-site

Manage the validation and qualification processes for developed MBR's, ensuring they meet user requirement and specification. · Documentation: Maintain comprehensive documentation of automation ...

3B Staffing LLC

Validation Engineer

Plainsboro, NJ · On-site

Software qualification experience (specifically for calibration software); equipment/process qualification experience with a preference for experience with temperature mapping (KAYE validator probes)

3B Staffing LLC

Validation Engineer

Plainsboro, NJ · On-site

Software qualification experience (specifically for calibration software); equipment/process qualification experience with a preference for experience with temperature mapping (KAYE validator probes)

Redolent, Inc.

US_West | Infrastructure Engineer_L3

NJ · On-site

$110K - $144K/yr

RESPONSIBILITIES: • Develop automation frameworks that allow silicon organizations to move fast with high confidence in the quality of prototyping, system provisioning, silicon/software validation ...

Leiters Inc

Validation Engineer

Buena, NJ · On-site

$97K - $121K/yr

The Validation Engineer reports directly to the Manager of Validation. The role is responsible for ... Demonstrated ability to conduct statistical analysis using software (JMP, MiniTab, Saas, etc.

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Software Validation information

What is software validation?

A Software Validation job involves ensuring that software meets its intended purpose and complies with regulatory or industry standards. Professionals in this role design and execute test plans, document findings, and work closely with developers to resolve issues. This position is common in industries like healthcare, automotive, and finance, where software reliability and compliance are critical. The goal is to verify that software operates correctly, safely, and effectively before release.

What does software validation do?

In a Software Validation role, your day typically involves developing and executing test cases, identifying and documenting software defects, and collaborating closely with development and quality assurance teams. You may also participate in requirement reviews, create validation reports, and ensure that software meets specified regulatory or industry standards. Many roles involve a mix of manual and automated testing tasks to comprehensively assess software performance and functionality. Regular communication with cross-functional teams is vital to resolve issues quickly and maintain product quality. This dynamic environment provides continuous learning and development opportunities, especially as new tools and standards are adopted.

What are the key skills and qualifications needed to thrive in software validation?

To thrive as a Software Validation professional, you need a solid understanding of software testing principles, validation methodologies, and quality assurance processes, often complemented by a degree in computer science, engineering, or a related field. Familiarity with test automation tools (such as Selenium or JUnit), validation frameworks, and compliance standards like ISO or FDA regulations is highly valuable. Attention to detail, analytical thinking, and effective communication skills help professionals excel in this role. These competencies are essential to ensure the reliability, safety, and compliance of software products before they reach end users.

What are popular job titles related to Software Validation jobs in New Jersey?

For Software Validation jobs in New Jersey, the most frequently searched job titles are:

What job categories do people searching Software Validation jobs in New Jersey look for?

The top searched job categories for Software Validation jobs in New Jersey are:

Software Validation jobs near you
Infographic showing various Software Validation job openings in New Jersey as of August 2026, with employment types broken down into 84% Full Time, 9% Part Time, 2% Temporary, and 5% Contract. Highlights an 85% Physical, 4% Hybrid, and 11% Remote job distribution.

Sr. Manager QA Validation Computerization Systems

Lynkx Staffing LLC

Saddle River, NJ

Full-time

Re-posted 20 days ago

Job description

Sr. Manager Quality Assurance Validation Computerization Systems The incumbent 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. 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.
  • Contributes 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.
  • Develops and evaluates 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
  • Bachelor’s Degree in a Scientific or Engineering discipline
  • 8 + years of computerized system experience with IT compliance/validation/qualification activities.
  • 8 + years of 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.
  • 10% travel required.
  • 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.
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.