Technology Compliance Specialist
About the job
- A bachelor's degree in Life Sciences, Engineering, Computer Science, Information Technology, or a related discipline, along with 5 or more years of relevant professional experience.
- At least 5 years of Computer System Validation experience within regulated GxP environments such as pharmaceutical, life sciences, medical device, or consulting organizations.
- At least 5 years of experience with risk management methodologies, including Failure Mode and Effects Analysis, and applying risk-based validation principles across the system lifecycle.
- At least 5 years of experience developing and executing Computer System Validation test scripts and creating validation deliverables such as risk assessments, traceability matrices, protocols, and validation reports.
- Strong working knowledge of GAMP 5, 21 CFR Part 11, EU GMP Annex 11, ISO 13485, Data Integrity ALCOA+, and GxP Quality Management System processes including CAPA, Change Control, Deviations, and Document Management.
- Partner with business, quality, and technical stakeholders to define intended system use and establish risk-based validation strategies for GxP computerized systems.
- Lead and facilitate risk assessments, including Failure Mode and Effects Analysis and data integrity evaluations, to identify compliance risks and ensure appropriate validation controls.
- Develop and maintain validation lifecycle documentation, ensuring traceability, technical accuracy, regulatory compliance, and audit readiness.
- Design and execute risk-based validation testing, assess defects and deviations, and drive resolution activities to maintain validated system status.
- Support Quality Management System processes including Change Control, CAPA, Deviations, and Document Management while ensuring appropriate Computer System Validation oversight.
- Evaluate cloud-based solutions, supplier validation evidence, and software releases to determine compliance impact and validation requirements.
- Collaborate across global functions to maintain inspection-ready systems, support audits, and continuously improve validation effectiveness and compliance processes.
- Experience with Kneat Gx, Veeva, ValGenesis, ALM, or similar validation management platforms.
- Experience applying Computer Software Assurance methodologies.
- Experience validating Cloud SaaS/PaaS solutions and performing supplier assessments.
- Experience supporting audits, inspections, software release assessments, and integrated GxP systems.
About the company
Koch Industries is a large, private, diversified conglomerate that operates in energy, chemical processing, and manufacturing. It started from an innovation that turned heavy crude oil into gasoline and grew through long‑term investments rather than short‑term market moves. The company generates value by refining fuels and producing chemical products, and it operates Georgia-Pacific, a major maker of paper and building products. Its business model relies on reinvesting most earnings back into the company to fund steady, long‑term growth rather than paying out frequent dividends or seeking quick profits. Koch differentiates itself from many competitors by staying privately owned, which reduces pressure from public markets and enables longer‑range planning. The company’s goal is to build scale and durability across its holdings by sustainable, multi‑decade growth rather than rapid, episodic gains.
Company Size
5,001-10,000
Company Stage
Growth Equity (Non-Venture Capital)
Total Funding
$985.2M
Headquarters
Wichita, Kansas
Founded
1940
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Simplify's Take
What believers are saying
- Koch raised $224.4 million in equity financing on March 10, 2026, preserving dry powder.
- Koch's Africa fertilizer foothold expands global phosphate reach from Morocco's Jorf complex.
- Closed Tacoma gypsum plant concentrates capital into stronger Georgia-Pacific assets and higher-margin lines.
What critics are saying
- DOJ opened a fertilizer antitrust probe in March 2026, risking criminal charges and damages.
- Farmers filed class actions in March and June 2026 against Koch Agronomic Services.
- Georgia-Pacific will close Tacoma's gypsum plant on October 30, 2026, cutting 125 jobs.
What makes Koch Industries unique
- Private since 1940, Koch reinvests earnings for decades, not quarterly Wall Street optics.
- Koch Fertilizer expanded into Morocco on June 30, 2026 through Jorf Fertilizers ownership.
- Georgia-Pacific and Koch Agronomic Services give Koch integrated positions across packaging and fertilizers.
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Benefits
- Health Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Disability Insurance
- Health Savings Account/Flexible Spending Account
- Paid Vacation
- Professional Development Budget
- Fertility Treatment Support
- Parental Leave
- Adoption Assistance
- Hybrid Work Options