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Qa Validation Jobs (NOW HIRING)

Danaher

Manager Quality Assurance, Validation

Chaska, MN · On-site

$130K - $160K/yr

The Quality Assurance Manager , Validations is located in Chaska, MN and reports to the Director of Quality Assurance. Our analyzers and reagents are medical laboratory devices used to calculate the ...

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How much do qa validation jobs pay per hour?

As of Aug 20, 2026, the average hourly pay for qa validation in the United States is $56.31, according to ZipRecruiter salary data. Most workers in this role earn between $41.59 and $70.43 per hour, depending on experience, location, and employer.

What is a QA Validation professional?

QA Validation professionals are specialists responsible for ensuring that products, processes, or systems meet defined quality standards and regulatory requirements. They design and execute tests, document results, and analyze data to confirm that all specifications are met before a product is released or a process goes live. Their work is crucial in industries such as pharmaceuticals, manufacturing, and software, where compliance and consistent quality are essential. QA Validation experts help prevent defects, ensure safety, and maintain customer trust.

What are the key skills and qualifications needed to thrive as a QA Validation professional?

To thrive as a QA Validation professional, you need a solid understanding of quality assurance processes, regulatory standards (such as FDA or ISO), and a relevant science or engineering degree. Familiarity with validation protocols, documentation systems, and tools like LIMS or TrackWise is typically required, along with certifications such as ASQ CQV or similar. Attention to detail, analytical thinking, and effective communication are essential soft skills for ensuring compliance and facilitating teamwork. These competencies are critical for guaranteeing product quality, regulatory compliance, and the smooth operation of validation activities in highly regulated industries.

What are some common challenges faced by QA Validation professionals in regulated industries?

QA Validation professionals in regulated industries often face the challenge of staying current with evolving compliance standards while ensuring that all processes and documentation meet strict regulatory requirements. They must balance thorough validation activities with tight project timelines, often collaborating closely with cross-functional teams such as manufacturing, engineering, and regulatory affairs. Attention to detail and strong organizational skills are essential, as even small errors can lead to costly delays or regulatory findings. Effective communication with team members and stakeholders is also critical to ensure successful audits and product launches.

What is the difference between Qa Validation vs Qa Analyst?

AspectQa ValidationQa Analyst
CertificationsGMP, GxP, Validation certificationsGMP, GxP, Quality assurance certifications
Work EnvironmentRegulated industries like pharma, biotechPharmaceutical, biotech, manufacturing
Primary FocusValidating processes, systems, equipmentAnalyzing quality data, audits, process improvements
Employer UsageQuality validation teams in regulated industriesQuality assurance departments across industries

Qa Validation specialists focus on validating systems and processes to ensure compliance with industry standards, often working on equipment and software validation. Qa Analysts primarily analyze quality data, perform audits, and support process improvements. While both roles ensure product quality, Qa Validation emphasizes validation activities, whereas Qa Analysts focus on ongoing quality analysis and reporting.

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QA Validation jobs near you
Infographic showing various Qa Validation job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 90% Full Time, 4% Part Time, and 5% Contract. Highlights an 84% Physical, 5% Hybrid, and 11% Remote job distribution, with an average salary of $117,123 per year, or $56.3 per hour.

Director, QA Validation & Computer Systems Assurance

Regeneron Pharmaceuticals, Inc (USA)

Saratoga Springs, NY • On-site

$180 - $240/hr

Other

Posted 9 days ago

Regeneron rating

8.4

Company rating: 8.4 out of 10

Based on 43 frontline employees who took The Breakroom Quiz

22nd of 86 rated pharmaceutical

Job description

Director of QA Validation

Build our future together: At Regeneron, we use science and innovation to develop life‑changing medicines for people with serious diseases. We are seeking a Director of QA Validation to lead the QA Validation, Computer Systems Assurance (CSA), and Equipment Assurance functions for the Regeneron manufacturing site located in Saratoga Springs, NY.

Location: Saratoga Springs, NY and Rensselaer, NY

Work model: Monday–Friday, 8:00am–4:30pm

Responsibilities
  • Own and maintain the site Validation Master Plan (VMP), including scope for process, cleaning, sterilization, utilities, and equipment qualification across GMP manufacturing areas.
  • Design and implement risk‑based qualification and requalification programs consistent with current FDA, EMA, and ICH guidance.
  • Ensure validation lifecycle documentation (URS, DQ, IQ, OQ, PQ, PV) meets regulatory expectations for commercial and clinical programs.
  • Lead periodic review programs to maintain validated state for equipment, utilities, and automated systems.
  • Lead the CSA program in alignment with FDA's 2022 CSA guidance and GAMP 5 (2nd ed.), shifting from prescriptive CSV toward risk‑based, fit‑for‑purpose assurance activities.
  • Own the site SDLC framework governing qualification and assurance of GxP‑relevant software and computerized systems.
  • Establish critical thinking and scripted/unscripted testing strategies based on software category, intended use, and risk to product quality and patient safety.
  • Oversee supplier/vendor assessments for software used in GxP contexts, including software development lifecycle practices and audit readiness.
  • Ensure data integrity by design across automated and integrated systems, including audit trail configuration, access controls, and electronic records compliance (21CFR Part11/Annex11).
  • Partner with IT, automation, and manufacturing engineering teams to integrate CSA requirements into system procurement, development, and change management processes.
  • Provide QA oversight for qualification of highly automated systems, including continuous manufacturing platforms, inline/online/atline PAT instruments, and automated material handling systems.
  • Partner with automation and digital transformation teams to ensure GxP requirements are embedded in future‑state manufacturing architecture, including digital twin environments.
  • Review and approve GxP documents, including validation protocols and reports, CSA plans and assessments, change controls, deviations/failure investigations, risk assessments, SOPs, and the VMP.
  • Provide QA validation and CSA oversight within the site change control system, ensuring impact assessments and requalification/revalidation requirements are properly scoped.
  • Maintain periodic review programs for validated processes and qualified systems, including metrics‑driven risk prioritization.
  • Present and defend validation and CSA programs during FDA, EMA, and other regulatory agency inspections; lead preparation of inspection‑ready documentation and staff readiness.
  • Monitor evolving regulatory guidance (FDA, EMA, PIC/S, USP) relevant to validation, CSA, data integrity, and computerized systems.
  • Lead, develop, and retain a team of validation scientists, engineers, and CSA specialists across a complex, multi‑system GMP environment.
  • Develop and manage validation and CSA budgets, contractor resources, and schedules; set performance objectives and manage hiring and separation activities.
  • Collaborate with Manufacturing, Engineering, Automation, IT, and Regulatory Affairs to align validation and CSA strategies with site priorities and enterprise digital initiatives; communicate program status and risk posture to senior leadership.
  • Support global quality alignment across Regeneron manufacturing facilities on validation and CSA standards and best practices.
Qualifications
  • BS/BA required in Engineering, Computer Science, Life Sciences, or related field; advanced degree preferred.
  • 12+ years of experience in pharmaceutical or biopharmaceutical manufacturing, including at least 7 years in validation, CSA, or quality assurance roles.
  • 5+ years of people management experience in a GxP environment.
  • Direct experience leading computer systems assurance or CSV programs for commercial biologics or pharmaceutical manufacturing sites required.
  • Working knowledge of SDLC methodologies applied to GxP software (GAMP5, 2nd ed.), FDA CSA guidance (2022), 21CFR Part11, EU Annex11, and ICHQ9(R1)/Q10.
  • Experience with MES, DCS/SCADA, LIMS, and ERP/EBR systems in a GMP context required.
  • Experience representing validation and CSA programs in regulatory inspections (FDA PAI, BPAI, or EMA inspections) preferred.
  • Strong working knowledge of risk management principles and their application to validation and software assurance decisions.
Equal Opportunity Statement

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.

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