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Kneat Jobs (NOW HIRING)

PSC Biotech

Cleaning Validation Engineer

Minneapolis, MN

$90K - $105K/yr

The engineer will author, execute, and route validation protocols within Kneat, perform on-site sampling activities, and support the successful completion of cleaning validation deliverables. Develop ...

Validation & Engineering Group, Inc

PR · On-site

Kneat experience preferred. Quality / Compliance / Documentation * Experience supporting: * Change Controls * CAPA implementation * SOP updates * Engineering documentation revisions * Technical ...

Validation & Engineering Group, Inc

PR · On-site

Kneat experience preferred. Quality / Compliance / Documentation * Experience supporting: * Change Controls * CAPA implementation * SOP updates * Engineering documentation revisions * Technical ...

Validation & Engineering Group, Inc

PR

Kneat experience preferred. Quality / Compliance / Documentation * Experience supporting: * Change Controls * CAPA implementation * SOP updates * Engineering documentation revisions * Technical ...

Validation & Engineering Group, Inc

PR

Kneat experience preferred. Quality / Compliance / Documentation * Experience supporting: * Change Controls * CAPA implementation * SOP updates * Engineering documentation revisions * Technical ...

Validation & Engineering Group, Inc

PR · On-site

Kneat experience preferred. Quality / Compliance / Documentation * Experience supporting: * Change Controls * CAPA implementation * SOP updates * Engineering documentation revisions * Technical ...

Validation & Engineering Group, Inc

PR

Kneat experience preferred. Quality / Compliance / Documentation * Experience supporting: * Change Controls * CAPA implementation * SOP updates * Engineering documentation revisions * Technical ...

Validation & Engineering Group, Inc

PR

Kneat experience preferred. Quality / Compliance / Documentation * Experience supporting: * Change Controls * CAPA implementation * SOP updates * Engineering documentation revisions * Technical ...

MMR Consulting

PR · On-site

Kneat or equivalent) * PMP certification preferred. * Experience with DeltaV, MES, SCADA, or other pharmaceutical automation platforms. * Familiarity with Kneat, TrackWise, Veeva, or electronic ...

Validation & Engineering Group, Inc

PR

Kneat experience preferred. Quality / Compliance / Documentation * Experience supporting: * Change Controls * CAPA implementation * SOP updates * Engineering documentation revisions * Technical ...

Validation & Engineering Group, Inc

PR

Kneat experience preferred. Quality / Compliance / Documentation * Experience supporting: * Change Controls * CAPA implementation * SOP updates * Engineering documentation revisions * Technical ...

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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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Infographic showing various Kneat job openings in the United States as of August 2026, with employment types broken down into 88% Full Time, and 12% Contract. Highlights an 97% Physical, 1% Hybrid, and 2% Remote job distribution.

6245 - Solution Prep Principal Engineer / Lead Validation Engineer

Verista, Inc.

Apex, NC • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 12 days ago

Job description

Description
Verista's 500 experts team up with the world's most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.
Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.
Company Culture Guidelines & Values:
  • We empower and support our colleagues
  • We commit to client success at every turn
  • We have the courage to do the right thing
  • We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
  • We constantly acquire new skills and learn from our experiences to enhance our collective expertise

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

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.
*Verista is an equal opportunity employer.
National (US) Range
$107,800-$168,011 USD
Benefits
Why Choose Verista?
  • High growth potential and fast-paced organization with a people-focused culture
  • Competitive pay plus performance-based incentive programs
  • Company-paid Life, Short-Term, and Long-Term Disability Insurance.
  • Medical, Dental & Vision insurances
  • FSA, DCARE, Commuter Benefits
  • Supplemental Life, Hospital, Critical Illness and Legal Insurance
  • Health Savings Account
  • 401(k) Retirement Plan (Employer Matching benefit)
  • Paid Time Off (Rollover Option) and Holidays
  • As Needed Sick Time
  • Tuition Reimbursement
  • Team Social Activities (We have fun!)
  • Employee Recognition
  • Employee Referral Program
  • Paid Parental Leave and Bereavement

Verista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.
For more information about our company, please visit us at Verista.com

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