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Experience With Valgenesis Jobs (NOW HIRING)

Experience with nasal or respiratory drug delivery systems, aseptic manufacturing, or cleanroom validation. * Working knowledge of validation tools and systems (e.g., TrackWise, ValGenesis, Veeva)

Experience with nasal or respiratory drug delivery systems, aseptic manufacturing, or cleanroom validation. * Working knowledge of validation tools and systems (e.g., TrackWise, ValGenesis, Veeva)

Experience with nasal or respiratory drug delivery systems, aseptic manufacturing, or cleanroom validation. * Working knowledge of validation tools and systems (e.g., TrackWise, ValGenesis, Veeva)

Experience with nasal or respiratory drug delivery systems, aseptic manufacturing, or cleanroom validation. * Working knowledge of validation tools and systems (e.g., TrackWise, ValGenesis, Veeva)

Experience * 8+ years of experience in pharmaceutical/biotech manufacturing. * 5+ years in CQV ... Familiarity with Kneat, ValGenesis, TrackWise, or similar systems (preferred). Soft Skills * Strong ...

Experience * 8+ years of experience in pharmaceutical/biotech manufacturing. * 5+ years in CQV ... Familiarity with Kneat, ValGenesis, TrackWise, or similar systems (preferred). Soft Skills * Strong ...

Experience * 8+ years of experience in pharmaceutical/biotech manufacturing. * 5+ years in CQV ... Familiarity with Kneat, ValGenesis, TrackWise, or similar systems (preferred). Soft Skills * Strong ...

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Experience With Valgenesis information

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How much do experience with valgenesis jobs pay per hour?

As of Jun 14, 2026, the average hourly pay for experience with valgenesis in the United States is $17.79, according to ZipRecruiter salary data. Most workers in this role earn between $17.79 and $17.79 per hour, depending on experience, location, and employer.

What is the difference between Experience With Valgenesis vs Clinical Data Coordinator?

AspectExperience With ValgenesisClinical Data Coordinator
Required CredentialsKnowledge of clinical data management systems, certifications in clinical researchTypically requires a degree in health sciences or related field, certifications in clinical data management
Work EnvironmentPharmaceutical or biotech companies, clinical research organizationsHospitals, research institutions, clinical trial sites
Industry UsageUsed in clinical data management, electronic data capture systemsManaging clinical trial data, ensuring data accuracy and compliance

Experience With Valgenesis involves working with electronic data capture systems in clinical research, focusing on data management and system proficiency. Clinical Data Coordinators handle clinical trial data collection and validation. Both roles require familiarity with clinical data processes, but Experience With Valgenesis emphasizes system-specific skills, while Clinical Data Coordinators focus on data integrity and compliance in clinical settings.

What is the ValGenesis?

ValGenesis is a digital validation platform used in regulated industries to manage and automate validation processes for manufacturing and quality systems. It helps ensure compliance with industry standards such as FDA and ISO by providing electronic documentation and audit trails. Professionals working with ValGenesis often need knowledge of validation protocols, regulatory requirements, and software implementation.

What is experience with ValGenesis and why is it important?

Experience with ValGenesis refers to familiarity and proficiency in using the ValGenesis platform, which is a digital validation lifecycle management system widely used in regulated industries like pharmaceuticals and biotechnology. Professionals with ValGenesis experience are adept at managing validation documents, automating workflows, and ensuring compliance with regulatory standards such as FDA and EMA requirements. This expertise is important because it helps organizations streamline validation processes, reduce errors, and maintain comprehensive audit trails, ultimately supporting product quality and regulatory compliance.

How does experience with ValGenesis impact collaboration within a quality assurance or validation team?

Having experience with ValGenesis significantly enhances collaboration within quality assurance and validation teams by streamlining documentation, approvals, and compliance workflows. As ValGenesis is an electronic validation lifecycle management system, familiarity with its platform enables team members to efficiently manage validation documents, track changes, and communicate updates in real-time. This reduces bottlenecks and improves transparency, allowing cross-functional teams—such as quality, IT, and manufacturing—to work together more effectively and maintain regulatory compliance. Employers often value candidates who can leverage ValGenesis to foster a more integrated and agile validation process.

Is ValGenesis a good company to work for?

ValGenesis is a company specializing in digital validation solutions, often hiring for roles related to software development, project management, and quality assurance. Employee reviews indicate a focus on innovation and a collaborative environment, but experiences can vary based on role and location.

What key skills and qualifications are needed to succeed in a role requiring experience with ValGenesis, and why are they important?

To excel in a position requiring experience with ValGenesis, you need a background in life sciences or engineering and a solid understanding of validation lifecycle management processes. Familiarity with the ValGenesis Validation Lifecycle Management System (VLMS), electronic documentation, and regulatory compliance standards such as FDA 21 CFR Part 11 is typically expected. Attention to detail, strong analytical thinking, and effective communication skills help individuals stand out in this role. These competencies are vital to ensure accurate, compliant, and efficient validation processes in regulated environments like pharmaceuticals or biotech.

What is the interview process for ValGenesis?

The interview process for a role involving ValGenesis typically includes an initial phone or video screening, followed by technical or skills assessments related to the company's software and quality management systems. Candidates may also participate in in-person interviews with team members and be evaluated on their understanding of validation processes and relevant tools.

What type of company is ValGenesis?

ValGenesis is a technology company that provides digital validation solutions for the life sciences and manufacturing industries. It specializes in cloud-based software to streamline validation processes, ensuring compliance with industry regulations. Employees in related roles often work with validation protocols, quality systems, and regulatory standards.
Infographic showing various Experience With Valgenesis job openings in the United States as of June 2026, with employment types broken down into 79% Full Time, and 21% Contract. Highlights an 86% In-person, and 14% Remote job distribution, with an average salary of $37,000 per year, or $17.8 per hour.
Computer System Validation Engineer

Computer System Validation Engineer

EXOS (formerly Sondhi Solutions)

Indianapolis, IN

Full-time

Posted 22 days ago


Job description

Position Overview:
The Computer Systems Validation Engineer supports validation lifecycle activities for automation and control systems within a regulated pharmaceutical manufacturing environment. This role works onsite at the customer manufacturing facility and collaborates closely with Automation Engineering, Information Technology, and site leadership to ensure systems remain in a validated state and compliant with global regulatory expectations.
Responsibilities:
  • Lead computer systems validation lifecycle activities for automation and control systems, including distributed control systems, programmable logic controllers, human machine interfaces, building management systems, and historian platforms.
  • Develop and execute validation plans, user requirements, functional specifications, design specifications, and configuration specifications for automation systems.
  • Author and execute installation qualification, operational qualification, and performance qualification protocols.
  • Generate and maintain requirements traceability matrices linking requirements through design, testing, and acceptance.
  • Author validation summary reports documenting validation outcomes, deviations, and acceptance rationale.
  • Perform 21 CFR Part 11 gap assessments for electronic records, electronic signatures, and audit trail compliance.
  • Conduct risk assessments, including GAMP 5 categorization and functional risk assessments.
  • Manage validation change control by assessing the impact of system changes, patches, and upgrades on the validated state.
  • Support periodic review activities to confirm systems remain in a validated state.
  • Define and execute the computer systems validation scope for the ServiceNow platform in collaboration with process owners.
  • Validate integrations between automation platforms and ServiceNow, including event connectors, configuration management database connectors, application programming interfaces, and access provisioning workflows.
  • Draft and maintain standard operating procedures related to computer systems validation.
  • Support audit readiness activities to ensure inspection-ready documentation aligned with FDA and EMA regulatory expectations.
  • Provide support for data integrity assessments across automation and historian systems as needed.
  • Assist with commissioning and qualification activities for new automation equipment.
  • Support remediation of validation findings from audits or regulatory inspections.
  • Advise on validation strategy for future automation system upgrades and expansions.

Required:
  • Demonstrated experience in computer systems validation for automation and control systems in a pharmaceutical or GMP regulated environment.
  • Strong knowledge of GAMP 5 methodology, validation lifecycle models, and risk-based validation approaches.
  • Experience with 21 CFR Part 11 compliance for electronic records and electronic signatures.
  • Proficiency in developing validation deliverables across the system development lifecycle.
  • Experience working with automation systems in a manufacturing environment.
  • Strong understanding of FDA and EMA regulatory expectations for computerized system validation.

Preferred:
  • Experience with ServiceNow platform validation or information technology service management system validation in a GxP environment.
  • Experience validating distributed control systems, historian platforms, or building automation systems.
  • Familiarity with data integrity principles including ALCOA plus.
  • Experience with electronic validation management systems such as Kneat or ValGenesis.
  • Life sciences manufacturing experience including biologics or advanced therapies.
  • Proficiency with Microsoft Word, Excel, and Visio for validation documentation and diagrams.