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Kneat Jobs (NOW HIRING)

Stefanini Group

Validation Specialist

Marion, NC · Hybrid

KNEAT Gx Lifecycle Management * Author, execute, review, and route validation documents within KNEAT Gx. * Maintain end to end traceability between: * User Requirements (URS). * Risk Assessments.

Validation & Engineering Group, Inc

PR

Responsible to simplify documentation, transfer documentation to Kneat and Tulip, support implementation and stabilization period. Transfer of cleaning documentation to new digital platform, all ...

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Chipton Ross Inc.

Senior Validation Specialist

Lancaster, NY · On-site

$61 - $61.48/hr

... KNEAT Gx. • Maintain end to end traceability between: • User Requirements (URS) • Risk Assessments • Test cases and protocols • Deviations and final reports • Ensure proper use of KNEAT ...

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PharmEng Technology Americas

PR · On-site

Kneat Gx platform digitizes and manages life cycle documentation, including design documentation, risk management, commissioning and qualification, validation documentation and testing. It releases ...

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PharmEng Technology Americas

PR · On-site

Kneat Gx platform digitizes and manages life cycle documentation, including design documentation, risk management, commissioning and qualification, validation documentation and testing. It releases ...

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Inteldot

Compliance Engineer

Gurabo, PR · On-site

Revise and maintain controlled documents using systems such as TrackWise (TV) and Kneat. * Support document lifecycle management, ensuring accuracy, completeness, and compliance with GMP requirements.

Intellectt INC

Validation Specialist

Indianapolis, IN · On-site

... KNEAT, Veeva, or Val Genesis. Experience supporting CAPEX projects, commissioning activities, and lab startup or site readiness initiatives is highly preferred. I would love to connect and discuss ...

Visium Resources, Inc.

Project Manager

Boulder, CO · On-site

Kneat or other software) is a major asset but not required. * Capital Improvements experience is a major asset but not required. Key Responsibilities: * Lead all CQV project activities for ...

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Weil Group, Inc

Process Engineer

Carolina, PR · On-site

Experience with Kneat application preferred. General process engineering support CAPAs and actions implementation Assessments execution and documentation Participate in investigations and problem ...

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Kneat information

What are the key skills and qualifications needed to thrive as a Kneat Validation Specialist, and why are they important?

To thrive as a Kneat Validation Specialist, you need a strong background in computer system validation, knowledge of GMP regulations, and experience in life sciences, often supported by a degree in a relevant field. Familiarity with the Kneat Gx platform, electronic validation tools, and documentation management systems is essential. Excellent analytical skills, attention to detail, and strong interpersonal communication help ensure thorough, compliant validation processes and smooth collaboration with cross-functional teams. These competencies are crucial for ensuring regulatory compliance, data integrity, and efficient validation workflows in highly regulated industries.

How does a role at Kneat typically collaborate with cross-functional teams in the implementation of digital validation solutions?

At Kneat, professionals regularly interact with cross-functional teams comprising IT, quality assurance, and business stakeholders to implement and optimize digital validation solutions. Collaboration often involves gathering requirements, customizing software workflows, and supporting user adoption through training and troubleshooting. Effective communication and project management skills are essential, as team members coordinate timelines, address challenges, and ensure regulatory compliance throughout the project lifecycle. This collaborative environment fosters continuous learning and exposure to diverse perspectives, which can accelerate professional growth.

What is a Kneat specialist?

A Kneat specialist is a professional who works with Kneat, a software platform widely used in regulated industries like pharmaceuticals and life sciences for managing validation, quality, and compliance documentation. These specialists are responsible for implementing, configuring, and supporting the Kneat software to streamline documentation processes and ensure regulatory compliance. Their role often involves collaborating with quality assurance, IT, and production teams to optimize workflows, train users, and maintain data integrity.
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Kneat jobs near you
Senior Validation Specialist - 2 Openings

Senior Validation Specialist - 2 Openings

DivIHN Integration Inc.

Marion, NC • On-site

Other

Posted 11 days ago

Key responsibilities

  • Execute and maintain validation activities for pharmaceutical and medical device manufacturing systems, including equipment, utilities, and computerized systems, using Kneat Gx.

  • Author, execute, review, and route validation documents within Kneat Gx while ensuring compliance with regulatory requirements and data integrity expectations.

  • Document and investigate validation deviations, support change control impact assessments, and participate in root cause analysis and CAPA implementation.

Job description

DivIHN (pronounced “divine”) is a CMMI ML3-certified Technology and Talent solutions firm. Driven by a unique Purpose, Culture, and Value Delivery Model, we enable meaningful connections between talented professionals and forward-thinking organizations. Since our formation in 2002, organizations across commercial and public sectors have been trusting us to help build their teams with exceptional temporary and permanent talent.

Visit us at to learn more and view our open positions.

 
Please apply or call one of us to learn more

For further inquiries about this opportunity, please contact one of our Talent Specialists, Remy at or Sri at
 
Title: Senior Validation Specialist - 2 Openings
Location: On-site at Marion, NC
Duration: 12  Months with possibilities of extension.
 
Only W2 candidates are eligible for this position. Third-party or C2C candidates will not be considered.
 
 
Description:
Role Overview
The Validation Specialist (Contract) will support pharmaceutical and medical device operations by executing and maintaining compliant validation activities using Kneat Gx as the electronic validation lifecycle management system. This role is focused on hands-on execution of validation deliverables to support equipment, process, utility, and computerized system readiness in accordance with FDA, ISO, and cGMP requirements.The specialist will work closely with Engineering, Quality, Automation, IT, and Operations to ensure systems and equipment are validated, audit ready, and capable of supporting safe, compliant production.
Key Responsibilities
  • Validation Execution (Primary Role)
  •  Execute IQ, OQ, PQ, requalification, and validation maintenance activities for pharma and medical device manufacturing systems.
  •  Support validation of:
  •  Manufacturing and packaging equipment
  • Utilities (compressed air, clean utilities, environmental controls)
  • Computerized systems (automation, data acquisition, MES, LIMS, vision systems)
  •  Apply risk based validation methodologies aligned with GAMP 5 and industry best practices.
KNEAT Gx Lifecycle Management
  • Author, execute, review, and route validation documents within KNEAT Gx.
  • Maintain end to end traceability between:
  • User Requirements (URS)
  • Risk Assessments
  • Test cases and protocols
  • Deviations and final reports
  • Ensure proper use of KNEAT Gx workflows, execution controls, and electronic approvals.
  • Maintain compliance with 21 CFR Part 11 and data integrity expectations.
Deviation, Change Control & CAPA Support
  • Document and investigate validation deviations within KNEAT Gx.
  • Support change control impact assessments affecting validated systems.
  • Participate in root cause analysis and CAPA implementation when required.
Regulatory & Quality Compliance
  • Ensure validation deliverables comply with:
  • FDA cGMP regulations (21 CFR Parts 210/211, Part 11)
  • ISO 13485 (Medical Devices)
  • Internal Quality Management System (QMS) requirements
  • Support regulatory inspections and customer audits by providing validation documentation and responses.
  • Maintain validation documentation in a state of continuous inspection readiness.
Cross Functional Support
  • Collaborate with Engineering, Quality, IT, Automation, Manufacturing, and external vendors.
  • Provide on floor support during commissioning, troubleshooting, and validation execution.
  • Support site initiatives such as new equipment introduction, line upgrades, remediation efforts, and capacity expansions.
Preferred Qualifications
  • Experience supporting medical device manufacturing under ISO 13485.
  • Experience with automation and controls (PLC/SCADA), vision systems, or MES.
  • Experience supporting high speed packaging or assembly lines.
  • Exposure to validation remediation or regulatory commitment work.
Core Competencies
  • Detail oriented with a strong compliance mindset
  • Ability to work independently under contract deliverables
  • Strong problem solving and root cause analysis skills
  • Effective communication with cross functional teams
  • Comfortable working in production and controlled environments
Work Conditions
  • On site support in a controlled GMP manufacturing environment
  • May require off shift or weekend support during execution windows
  • PPE and gowning requirements may apply depending on area
About us:
DivIHN, the ''IT Asset Performance Services'' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.

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