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Kneat Jobs in Raleigh, NC (NOW HIRING)

PSC Biotech

Senior Validation Engineer

Durham, NC · On-site

$120K - $140K/yr

Author, execute, and review validation documentation within the KNEAT platform. * Support Computer System Validation (CSV) activities. * Perform risk assessments and apply risk-based validation ...

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PSC Biotech

Senior Validation Engineer

Durham, NC · On-site

Author, execute, and review validation documentation within the KNEAT platform. Support Computer System Validation (CSV) activities. Perform risk assessments and apply risk-based validation ...

PSC Biotech

Senior Validation Engineer

Durham, NC · On-site

Author, execute, and review validation documentation within the KNEAT platform. * Support Computer System Validation (CSV) activities. * Perform risk assessments and apply risk-based validation ...

Visium Resources, Inc.

Be Seen First

Pharmaceutical Engineer

Raleigh, NC · On-site

$120K - $145K/yr

Kneat or electronic validation systems * PMP certification or equivalent project leadership experience is a plus. * Strong client-facing communication and leadership skills. Additional Skills ...

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Kneat information

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.

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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Infographic showing various Kneat job openings in Raleigh, NC as of August 2026, with employment types broken down into 76% Full Time, 1% Part Time, 1% Temporary, and 22% Contract. Highlights an 97% Physical, 1% Hybrid, and 2% Remote job distribution.

6245 - Solution Prep Principal Engineer / Lead Validation Engineer

Verista, Inc.

Apex, NC

Full-time

Re-posted 6 days ago

Job description

We are seeking a Solution Prep Principal Engineer with hands-on experience supporting solution preparation systems within biopharmaceutical manufacturing environments. This role will focus on solution preparation, buffer preparation, and media preparation unit operations, supporting commissioning, qualification, and validation activities to ensure systems are designed, installed, tested, and qualified in compliance with cGMP and regulatory expectations.

The ideal candidate will have strong experience across the CQV lifecycle, including authoring validation documentation, supporting equipment startup and commissioning activities, coordinating vendor testing, and ensuring systems achieve operational readiness. Experience working within digital validation platforms such as Kneat is highly desirable.

This position requires an individual who can work independently while collaborating cross-functionally with engineering, automation, vendors, and quality teams to ensure successful project execution.

Solution Preparation Principal Engineer Responsibilities:Commissioning, Qualification & Validation

  • Support commissioning, qualification, and validation (CQV) activities for solution preparation systems used in biopharmaceutical manufacturing.

  • Author, review, and execute CQV lifecycle documentation including:

    • Commissioning test protocols

    • Installation Qualification (IQ)

    • Operational Qualification (OQ)

    • Performance Qualification (PQ)

    • Validation summary reports

  • Ensure validation documentation complies with cGMP regulations and internal quality procedures.

  • Participate in system impact assessments, risk assessments, and validation planning activities.

Solution Preparation Process Support

  • Provide technical support for solution preparation unit operations, including systems such as:

    • Buffer preparation systems

    • Media preparation systems

    • Solution preparation tanks and mixing systems

    • Single-use mixing systems

    • Transfer and hold systems

  • Support equipment startup and operational readiness for solution preparation processes.

  • Assist with troubleshooting and process verification during commissioning and qualification activities.

Vendor & Equipment Startup

  • Support Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for new equipment.

  • Coordinate with equipment vendors and system integrators to ensure systems are installed and functioning according to design specifications.

  • Participate in equipment startup, commissioning, and operational testing activities.

Cross-Functional Coordination

  • Collaborate with engineering, automation, quality assurance, and manufacturing teams to align project deliverables.

  • Assist with deviation investigations, change control processes, and documentation updates.

  • Ensure CQV activities align with project schedules and operational readiness milestones.

Digital Validation Systems

  • Utilize electronic validation platforms (e.g., Kneat) to develop, manage, and execute validation documentation.

  • Maintain data integrity, traceability, and compliance within digital validation systems.

Requirements:

  • Bachelor's degree in Engineering, Biotechnology, Life Sciences, or related technical field

  • 10+ years of role specific experience

  • Experience supporting CQV activities within GMP-regulated pharmaceutical or biotechnology environments

  • Hands-on experience with solution preparation, buffer prep, or media prep systems

  • Strong understanding of CQV lifecycle documentation (IQ/OQ/PQ protocols and reports)

  • Ability to work independently while coordinating with cross-functional teams

  • Strong technical documentation and communication skills

  • Experience using digital validation platforms such as Kneat

  • Experience supporting FAT/SAT, commissioning, and equipment startup

  • Familiarity with single-use systems and biologics manufacturing processes

  • Experience working within biologics or cell culture manufacturing facilities

  • Onsite job requirement in Apex, NC

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