Senior Engineer, Digital Systems Quality Assurance

Madison-Davis, LLC; Bridgewater Township (NJ); Hybrid; USD 140.000 - 190.000; Vollzeit

Zusammenfassung

Madison-Davis, LLC seeks a Senior Engineer, Digital Systems Quality Assurance to oversee compliance and validation of enterprise computerized systems in a GxP environment.

You will provide hands-on validation expertise across lifecycle stages and support QA oversight of changes, upgrades, and migrations, working with IT, QA, and business owners to ensure systems remain inspection-ready.

Qualifikationen

• Hands-on GxP computer system validation experience.
• Strong knowledge of validation documentation, testing, and traceability.
• Experience across multiple stages of the system lifecycle.
• Excellent collaboration with IT, QA and business system owners.

Aufgaben

• Lead or support end-to-end computerized system validation, including planning, requirements, risk assessments, qualification protocols, testing, and reporting.
• Apply risk-based validation approaches aligned with FDA/EU expectations.
• Review, author, and approve validation deliverables and QA documentation.
• Provide QA oversight for system implementations, upgrades, data migrations, and change controls.
• Conduct periodic reviews and audit-trail assessments, user-access reviews, and related compliance activities.
• Collaborate with stakeholders on compliant validation for emerging digital systems.

Kenntnisse

GxP Validation

Regulatory compliance

Lifecycle management

Cross-functional collaboration

Ausbildung

Bachelor’s degree in science/engineering

Tools

Veeva Vault

ServiceNow GxP

Jobbeschreibung

A global life sciences organization is seeking an experienced Senior Engineer, Digital Systems Quality Assurance to support the regulatory compliance and validation of enterprise computerized systems. This position is responsible for providing hands-on GxP Computer System Validation expertise and Quality Assurance oversight across system implementations, change-control activities, operational reviews, and ongoing lifecycle management. The successful candidate will work closely with IT, Quality Assurance, and business system owners to ensure that regulated digital systems remain compliant, appropriately validated, and inspection-ready.

RESPONSIBILITIES

• Lead or support end-to-end computerized system validation, including planning, requirements, risk assessments, qualification protocols, testing, and reporting.
• Apply risk-based validation approaches consistent with FDA and European regulatory expectations.
• Review, author, and approve validation deliverables and supporting quality documentation.
• Provide QA oversight for GxP system implementations, upgrades, data migrations, and change controls.
• Conduct or oversee periodic reviews, audit-trail assessments, user-access reviews, and related compliance activities.
• Evaluate system changes to determine appropriate validation and revalidation requirements.
• Participate in supplier qualification, vendor assessments, and regulatory inspection preparation.
• Support computerized system lifecycle management, including controlled retirement and decommissioning.
• Collaborate with technology and quality stakeholders on compliance considerations for emerging digital systems.

Role Requirements

• Minimum 5 years of hands-on GxP Computer System Validation experience.
• Demonstrated experience leading validation activities across multiple stages of the computerized system lifecycle.
• Strong knowledge of 21 CFR Part 11 and EU Annex 11.
• Familiarity with ISPE GAMP 5 and FDA Computer Software Assurance principles.
• Experience validating enterprise computerized systems in a regulated GxP environment.
• Strong knowledge of validation documentation, testing, traceability, risk assessments, and change-control practices.
• Understanding of quality oversight, regulatory compliance, and maintaining systems in a validated state.
• Strong cross-functional communication and collaborative problem-solving abilities.
• Bachelor's degree in a relevant scientific, engineering, or technology discipline.
• Ability to work onsite in Bridgewater, NJ, two days per week.

PREFERRED EXPERIENCE

• 7+ years of pharmaceutical or biotechnology computerized system validation experience.
• Experience with enterprise GxP applications such as Veeva Vault, ServiceNow GxP, or similar systems.
• Experience validating clinical or laboratory computerized applications.
• Supplier qualification, vendor auditing, or regulatory inspection support.
• Familiarity with AI/ML-enabled GxP systems and evolving regulatory expectations.