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Kneat Jobs in Raleigh, NC (NOW HIRING)

Flexware Innovation

DeltaV Engineer

Raleigh, NC · On-site

KNEAT Gx * GAMP5, ALCOA++, Data Integrity * This role is located in the Raleigh and surrounding areas. To be successful in this position, you are expected to be on site in a client facility. We are ...

AA2IT

Senior Project Quality Engineer - III

Durham, NC · On-site

$80K - $108K/yr

... with Kneat (Validation Execution System), SAP, Trackwise and/or GLIMS *Note*: This is onsite role at Durham, NC for 1 year with possibility of extension. Responsibilities: Senior Specialist ...

AA2IT

Senior Project Quality Engineer - III

Durham, NC · On-site

$80K - $108K/yr

... with Kneat (Validation Execution System), SAP, Trackwise and/or GLIMS *Note*: This is onsite role at Durham, NC for 1 year with possibility of extension. Responsibilities: Senior Specialist ...

Fujifilm

Specialist, Quality Assurance

Durham, NC · On-site

Experience with Trackwise, SAP, Kneat and/or Veeva Working Conditions & Physical Requirements: * Will work in environment which may necessitate respiratory protection * Ability to stand for prolonged ...

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Kneat information

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.

What are the key skills and qualifications needed to thrive as a Kneat validation specialist?

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.

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For Kneat jobs in Raleigh, NC, the most frequently searched job titles are:

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The top searched job categories for Kneat jobs in Raleigh, NC are:

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Cities near Raleigh, NC with the most Kneat job openings:

Kneat jobs near you
Infographic showing various Kneat job openings in Raleigh, NC as of August 2026, with employment types broken down into 90% Full Time, 4% Part Time, and 6% Contract. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution.

6243 - Downstream Principal Engineer / Lead Validation Engineer

Verista, Inc.

Holly Springs, NC • On-site

Full-time

Re-posted 3 days ago

Job description

We are seeking a Downstream Principal Engineer is responsible for overseeing the commissioning and qualification of downstream systems. This role ensures that all systems are designed, tested, and documented in alignment with project requirements and safety standards.

Downstream Principal Engineer Responsibilities:Downstream System Leadership
  • Serve as the commissioning and qualification lead for Downstream systems (responsibilities described below).
  • Specific experience with chromatography systems, TFF filtration systems, viral filtration systems, and UFDF filtration systems.
C&Q Lead ResponsibilitiesCommissioning and Qualification Documentation
  • Gain a thorough understanding of system design by reviewing engineering documentation, P&IDs, and design specifications.
  • Develop User Requirement Specifications (URS) and Quality Risk Assessment for Equipment and Automated Systems (QRAES).
  • Engage with design engineers and SMEs to clarify system intent and operational requirements.
  • Ensure alignment with quality, automation, and engineering teams on critical parameters and documentation.
  • Create Commissioning Test Plans that translate design intent into testable steps.
  • Coordinate with the Automation Team to incorporate all automation functional testing.
  • Collaborate with SMEs to ensure system requirements are accurately reflected in test plans.
  • Develop Installation, Operational, and Qualification (IOQ) protocols.
  • Prepare and submit summary reports documenting commissioning and qualification activities.
System Ownership and Execution
  • Take custody of the system post-construction and maintain ownership through C&Q completion.
  • Perform Lockout/Tagout (LOTO) for system safety.
  • Conduct pre-startup safety checks and risk assessments.
  • Prepare daily pre-task plans and verify team readiness for safe execution.
  • Attend daily commissioning meetings to coordinate activities.
  • Execute commissioning and IOQ protocols.
  • Resolve issues arising during execution.
  • Participate in Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs) as required.
Requirements:
  • Bachelor's degree in Engineering, Life Sciences, Biotechnology, or related technical discipline
  • 10+ years of role specific experience
  • Experience supporting CQV activities in GMP-regulated pharmaceutical or biotechnology environments
  • Hands-on experience with downstream bioprocess equipment and purification systems
  • Strong understanding of validation lifecycle documentation (IQ/OQ/PQ, protocols, reports)
  • Ability to work independently while collaborating with cross-functional teams
  • Strong documentation, organizational, and communication skills
  • Experience with digital validation systems such as Kneat
  • Experience supporting FAT/SAT, commissioning, and equipment startup
  • Familiarity with risk-based validation approaches
  • Experience in biologics manufacturing or monoclonal antibody production environments
  • Onsite job requirement in Holly Springs, NC

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