---
title: 'Validation Engineer - Kentucky at Valspec'
canonical: 'https://feeny.ai/job/validation-engineer-kentucky-valspec-non-headquarters-65fxamcdxehh'
type: 'job'
last_seen: '2026-09-08'
---

# Validation Engineer - Kentucky at Valspec

- **Company:** Valspec
- **Location:** Non-Headquarters
- **Posted:** 2026-08-24
- **Last confirmed live:** 2026-09-08
- **Apply:** https://job-boards.greenhouse.io/valspec/jobs/6151871004

## Job description

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.

Senior CQV Engineer (Cleaning Validation & Data Integrity)

Location: Lexington, KY (Onsite) Duration: 6+ Month Contract Travel/Per Diem Available Industry: Pharmaceutical / Animal Health Manufacturing

## About the Opportunity

Valspec is seeking a Senior CQV Engineer to support a high-impact Cleaning Validation and Data Integrity initiative at a pharmaceutical manufacturing facility in Lexington, Kentucky.

This consultant will lead validation activities supporting manufacturing suites, process equipment, and laboratory systems within a regulated GMP environment. The project includes development and execution of cleaning validation strategies, remediation planning, SOP creation, data integrity assessments, and cross-functional collaboration with Engineering, Quality, Manufacturing, and Laboratory teams.

The facility manufactures veterinary pharmaceutical products in powder, tablet, and granule dosage forms and operates multiple manufacturing suites as well as quality control laboratory operations utilizing HPLC, stability, incubation, dissolution, and analytical testing equipment.

## Responsibilities

- Lead Cleaning Validation activities from planning through execution
- Develop and execute cleaning validation protocols and reports
- Design and support swab recovery studies and cleaning validation methods
- Establish worst-case product and equipment groupings using scientific and risk-based approaches
- Support protocol execution and field verification activities within manufacturing operations
- Author and revise validation documentation including:
- Validation Plans
- Risk Assessments
- Protocols
- Summary Reports
- SOPs
- Remediation Plans
- Evaluate existing cleaning procedures and implement improvements where necessary
- Perform Data Integrity assessments on laboratory systems and equipment
- Identify compliance gaps and develop corrective actions and remediation strategies
- Partner with Quality and Regulatory stakeholders to ensure alignment with current GMP expectations
- Support investigations, deviations, and change control activities related to validation programs
- Provide technical leadership and mentorship to project team members as required

Required Qualifications

- Bachelor's Degree in Engineering, Chemistry, Life Sciences, Pharmaceutical Sciences, or related discipline
- 10+ years of CQV, Validation, or Quality Engineering experience within regulated pharmaceutical, biotech, medical device, or animal health manufacturing environments
- Demonstrated Cleaning Validation experience including protocol development and execution
- Strong understanding of current GMP regulations and FDA expectations
- Experience authoring and reviewing validation lifecycle documentation
- Experience executing IQ/OQ/PQ activities for manufacturing and laboratory equipment
- Proven ability to work independently and interact directly with client leadership
- Excellent technical writing and communication skills

## Preferred Qualifications

- Oral solid dose manufacturing experience
- Experience supporting powder, blending, tableting, filling, packaging, or related pharmaceutical operations
- Swab method development and recovery study experience
- Data Integrity assessment and remediation experience
- Laboratory equipment qualification experience
- Familiarity with HPLC, dissolution, stability, incubation, and analytical laboratory systems
- Experience supporting FDA inspections and audit readiness initiatives
- Previous consulting experience within pharmaceutical manufacturing environments

Ideal Candidate

We are seeking a hands-on consultant who can operate as both a technical subject matter expert and a project leader. The ideal candidate is comfortable working directly with Quality, Manufacturing, Engineering, and Laboratory stakeholders while driving validation deliverables independently.

Candidates with strong CQV backgrounds from biotech facilities are encouraged to apply, particularly those who have supported equipment qualification, validation remediation programs, laboratory systems, and cleaning validation initiatives.

Why This Project?

- Long-term onsite engagement in Lexington, KY
- Travel and per diem support available
- High-visibility project with direct client interaction
- Blend of Cleaning Validation and Data Integrity initiatives
- Opportunity to lead validation strategy and execution rather than simply execute protocols
- Immediate impact within a regulated GMP manufacturing environment

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.

## About Valspec

## Company Overview
- **One-liner**: Valspec provides end-to-end digital and conventional lifecycle services—validation, compliance, and systems assurance—for highly regulated life sciences organizations.
- **Entity Type**: Private (Privately Held)
- **Headquarters**: Royersford, Pennsylvania, United States
- **Founded**: 1999
- **Founders**: Not publicly available

## Core Business
- **Primary industry**: Life sciences services (biopharma, cell and gene therapy, advanced manufacturing)
- **Target customers**: B2B – life sciences manufacturers, biotech and pharmaceutical companies
- **Mission**: “Deliver trusted lifecycle solutions that streamline digital and conventional systems and drive critical milestones toward market success.”

## Products & Services
Valspec offers a suite of lifecycle services, not packaged products. Key service lines include:

- **eVLM Implementation & Qualification**: Deploy and qualify compliant electronic validation lifecycle management systems.
- **Software & Systems Assurance**: Validation and compliance for enterprise software (e.g., ERP, LIMS, MES).
- **Data Governance & Integrity**: Secure and govern critical GxP data.
- **IT/OT Infrastructure**: Design, implement, and qualify robust IT and operational technology environments.
- **Digital Solutions & AI**: Practical AI and digital solutions to accelerate performance.
- **Manufacturing Systems Qualification**: CSV and CQV for manufacturing equipment and automation.
- **Specialized Expertise**: Serialization (DSCSA compliance), single-use technologies, upstream/downstream purification, cell culture & fermentation, media & buffer prep, recovery, cleaning & sterilization, continuous manufacturing, fill/finish facilities.

## Market Standing
- **Valuation/Market Cap**: Not disclosed
- **Key Metric**: Annual revenue of approximately $5.9M (latest estimate); 50 employees; 1,900+ projects executed across 185+ client sites.
- **Notable Investors/Partners**: Strategic partnerships with **Blue Mountain** (2024) and **ValGenesis** (2023). Talent sources include AVEVA, RoviSys, Emerson, Novartis, Regeneron, GSK.
- **Growth Signals**: 14 active job postings (as of mid-2026); headcount declined 5.5% YoY, but the company continues to hire for validation engineers and project managers. Recent strategic partnerships signal expansion in digital lifecycle solutions.

## Competitive Advantages
- **End-to-end lifecycle coverage**: From validation roots to full lifecycle leadership (data governance, IT/OT, digital solutions, AI) under one roof.
- **Deep domain expertise**: 25+ years exclusively in life sciences, with repeatable processes for highly regulated environments.
- **Quality-first mindset**: 100% commitment to compliance and inspection readiness; known for “precision with purpose.”
- **Flexible engagement models**: Short-term support to full lifecycle leadership; on-site, remote, or hybrid delivery.

## Strategic Focus
- Expand digital solutions and AI capabilities for life sciences.
- Strengthen partnerships (e.g., Blue Mountain, ValGenesis) to deliver integrated manufacturing and validation platforms.
- Maintain leadership in compliance and data integrity as regulatory demands evolve.
- Continue to invest in talent to support client needs across North America.

## Why Work Here
- **Culture**: “People First” – described as a family culture where colleagues are friends, retention is high, and individuality is valued.
- **Flexibility**: Work from home, customer sites, or office; variety in day-to-day work.
- **Career Development**: Ongoing learning, advancement opportunities, and support for career goals.
- **Employee Ratings** (13 reviews on LinkedIn): Overall 3.8/5.0; Work-Life Balance 4.6, Culture 4.2, Career 3.8, Compensation 3.6.
- **Impact**: Work on life-changing therapies; projects directly support bringing drugs and treatments to patients.

## Sources
1. [valspec.net – Homepage](https://valspec.net/)
2. [valspec.net – About Us](https://valspec.net/about-us/)
3. [valspec.net – Careers](https://valspec.net/careers/)
4. [valspec.net – Expertise](https://valspec.net/expertise/)
5. [LinkedIn – Valspec Company Page](https://www.linkedin.com/company/valspec)
6. [PR Newswire – Blue Mountain Partnership](https://www.prnewswire.com) (referenced in LinkedIn news, but exact URL not provided; use LinkedIn for news mentions)
7. [PR Newswire – ValGenesis Partnership](https://www.prnewswire.com) (same note)

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- [Startup & Operational Readiness Manager](https://feeny.ai/job/startup-operational-readiness-manager-valspec-non-headquarters-k1hhraapgfcm) — Non-Headquarters
- [Documentation / Data Lead](https://feeny.ai/job/documentation-data-lead-valspec-non-headquarters-2cmx0ja0y32a) — Non-Headquarters
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