Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec’s mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals.

Valspec’s projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies.

Kneat SME / Digital Validation Consultant

Location: Pennsylvania (Hybrid/Onsite Preferred)
Company: Valspec
Industry: Life Sciences | Biopharmaceutical Manufacturing

Join Valspec and Help Transform Digital Validation

Valspec is seeking an experienced Kneat Subject Matter Expert (SME) to support a major digital validation initiative at a leading biopharmaceutical manufacturing facility in Pennsylvania.

This role is ideal for a consultant who has successfully implemented, administered, or expanded Kneat within regulated GxP environments and is passionate about helping organizations transition from traditional paper-based validation processes to sustainable digital validation programs.

You will serve as the primary Kneat expert, partnering with Quality, Validation, Engineering, Manufacturing, and IT teams to drive adoption, standardize processes, migrate existing qualification content, and establish best practices for long-term success.

What You'll Do

Kneat Leadership & Deployment

• Act as the site SME for the Kneat platform and paperless validation processes.
• Lead or support Kneat implementations, enhancements, and expansion initiatives.
• Develop and execute deployment strategies, governance models, and adoption plans.
• Facilitate workshops and collaborate with stakeholders to define business and validation requirements.
• Drive continuous improvement of digital validation processes.

Content Conversion & Digital Validation

• Convert existing qualification, commissioning, validation, and lifecycle documentation into Kneat.
• Develop reusable templates, libraries, workflows, and document structures.
• Configure and optimize approval workflows, execution processes, and traceability within the platform.
• Support document execution, review, approval, and closure activities.

CSV & Compliance

• Lead Computer System Validation (CSV) activities associated with Kneat and related validation technologies.
• Develop and review validation deliverables including:
  • Validation Plans
  • User Requirements Specifications (URS)
  • Functional Specifications
  • Risk Assessments
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Traceability Matrices
  • Validation Summary Reports
  • SOPs and Work Instructions
• Ensure compliance with GxP regulations, 21 CFR Part 11, Data Integrity requirements, and industry best practices.

Training & Change Management

• Train end users, power users, validation engineers, and quality personnel.
• Provide ongoing support and troubleshooting for Kneat users.
• Mentor cross-functional teams on paperless validation methodologies.
• Promote user adoption and long-term sustainability of digital validation processes.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, Computer Science, or a related discipline.
• 5+ years of Computer System Validation (CSV), CQV, Validation, or Quality Systems experience in the pharmaceutical, biotech, or medical device industry.
• Hands-on Kneat experience as an administrator, author, reviewer, approver, or implementation lead.
• Experience supporting paperless validation initiatives in regulated GxP environments.
• Strong understanding of:
  • GAMP 5
  • ASTM E2500
  • 21 CFR Part 11
  • Data Integrity principles
  • Software Development Lifecycle (SDLC)
• Experience developing and executing validation protocols and risk assessments.
• Outstanding communication and stakeholder management skills.
• Ability to lead discussions, influence decisions, and drive project deliverables.

Preferred Qualifications

• Previous Kneat deployment or site expansion experience.
• Experience with Commissioning, Qualification, and Validation (CQV) programs.
• Experience supporting large capital projects or manufacturing facilities.
• Prior experience with ValGenesis, Veeva, ALM/Quality Center, TrackWise, MasterControl, or other validation and quality platforms.
• Experience creating and maintaining digital validation libraries and template structures.

Why Join Valspec?

At Valspec, you'll work alongside industry experts helping some of the world's leading pharmaceutical manufacturers modernize their validation programs. This is an opportunity to make a lasting impact by building scalable digital validation solutions that improve compliance, efficiency, and quality across critical manufacturing operations.

If you're the person others turn to when they have a Kneat question, we'd love to hear from you.

Why Join Valspec?

At Valspec, we offer more than just a job — we provide a career experience rooted in a standout culture, collaborative environment, and a strong sense of ownership. As an Employee Stock Ownership Plan (ESOP) company, every team member has a stake in our success, fostering a shared commitment to excellence and innovation.  We also offer a highly competitive benefits package, including:

• Premium medical coverage
• 401(k) with company match
• Tuition reimbursement
• Unique performance incentives
• And more — all designed to support your growth, well-being, and future.

Join a team where your contributions matter, your development is prioritized, and your success is shared.

When receiving e-mails from a Proconex or Valspec recruiter, you will only receive e-mails from addresses ending in @proconexdirect.com, @proconex.net or @valspec.net.  Any other domains are impersonations and should be ignored.

Candidates must be legally eligible to work in the United States without company sponsorship.  Also, we are not interested in working on a corp-to-corp basis with other companies at this time.

Any third-party unsolicited resume submission(s) will immediately become the property of Valspec. Valspec will not pay any fee to a submitting employment agency, person, or entity unless a signed agreement is established.

Valspec is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to sex, race, color, religion, national origin, age, sexual orientation, gender identity, disability, protected veteran status or any other protected class. We are committed to providing a professional environment free of any discrimination or harassment, and we are proud to be a Drug-Free Workplace.