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Kneat Jobs in Indiana (NOW HIRING)

Stark Pharma Solutions Inc

CQV Lead

Indianapolis, IN · On-site

Experience with KNEAT documentation and qualification workflows . * Exposure to process equipment such as TFF systems, bioreactors , or related manufacturing technologies. * Experience with GMARS or ...

Mace

Document Control Lead

Indianapolis, IN · Hybrid

Oversee the TMP's integration and use of Client's document and data systems (EIDA, Kneat, MCPlus, EPIC, Aconex, Procore, and Unifier), confirming each operates as the controlled system of record for ...

INCOG

Associate Director of Enterprise Systems

Fishers, IN · On-site

$100K - $124K/yr

VMS (e.g., Kneat) * MES (e.g. Rockwell PharmaSuite, Apprentice, Tulip) * Other regulated enterprise systems supporting Manufacturing, Quality, Engineering, Supply Chain, and Finance The Associate ...

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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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Kneat jobs near you
Infographic showing various Kneat job openings in Indiana as of August 2026, with employment types broken down into 89% Full Time, 5% Part Time, and 6% Contract. Highlights an 96% Physical, 1% Hybrid, and 3% Remote job distribution.

Process Validation Engineer

Katalyst Healthcares and Lifesciences

Indianapolis, IN • On-site

Other

This job post has expired today. Applications are no longer accepted.

Job description

Job Description:
We are seeking a Process Validation Engineer to support validation and qualification activities in a GMP-regulated manufacturing environment. The ideal candidate will have experience with process validation, equipment qualification, CSV, temperature mapping, and regulatory compliance.
Responsibilities:
  • Execute process validation and equipment qualification activities (IQ, OQ, PQ, PPQ).
  • Develop, review, and maintain validation protocols and reports.
  • Support Computer Systems Validation (CSV) activities.
  • Perform temperature mapping studies and analyze validation data.
  • Utilize Kneat or similar electronic validation management systems.
  • Support commissioning, qualification, and validation (CQV) projects.
  • Investigate deviations and support CAPA and change control activities.
  • Ensure compliance with GMP, FDA, and regulatory requirements.
  • Collaborate with Engineering, Manufacturing, Quality, and Regulatory teams.

Requirements:
  • Bachelor's degree in Engineering, Science, or a related field.
  • Experience in process validation, equipment qualification, or validation engineering.
  • Knowledge of IQ/OQ/PQ and validation lifecycle activities.
  • Familiarity with CSV principles and regulatory requirements.
  • Experience with Kneat, Ellab, or similar validation tools is preferred.
  • Understanding of GMP/cGMP regulations.
  • Strong documentation, communication, and problem-solving skills.

Preferred Skills:
  • Process Validation.
  • Equipment Qualification.
  • CSV (Computer Systems Validation).
  • Temperature Mapping.
  • Kneat.
  • Ellab Systems.
  • GMP/cGMP Compliance.
  • CAPA and Change Control.

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