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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 ...

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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.

Computer System Validation Engineer

Indianapolis, IN • On-site

Stark Pharma Solutions Inc
See more jobs at Stark Pharma Solutions Incexternal

Contractor

Re-posted 28 days ago

Job description

Job Title: Validation Engineer

Location: Indianapolis / Bloomington, IN (100% Onsite)

Duration: Long term Contract

Interview Mode: Onsite (Local candidates preferred)

Job Summary:

We are seeking a Validation Engineer with strong experience in Computer Systems Validation (CSV), equipment qualification, and GMP-regulated environments. The ideal candidate will support validation activities, documentation migration, and equipment qualification to ensure compliance with regulatory standards.

Key Responsibilities

  • Lead migration of legacy validation documents into the Kneat digital platform, ensuring accuracy and compliance
  • Perform equipment qualification for lab instruments (pH meters, thermal mixers, peristaltic pumps, nutating mixers, etc.)
  • Execute temperature mapping studies, including work with Ellab systems or similar equipment
  • Support Computer Systems Validation (CSV) activities and documentation
  • Assist Process Engineering teams to ensure project timelines and milestones are met
  • Ensure all validation activities comply with GMP and regulatory requirements
  • Maintain clear, accurate, and compliant documentation

Required Qualifications:

  • Bachelor’s degree in Engineering, Science, or related field
  • 6+ years of experience in Computer Systems Validation (CSV)
  • 4+ years of experience in pharmaceutical manufacturing environment
  • Hands-on experience with equipment qualification and validation
  • Strong knowledge of CSV principles and regulatory compliance
  • Experience working in onsite, fast-paced environments