Senior Engineer, Digital Systems Quality Assurance

A global biopharmaceutical organization is seeking a Senior Engineer to provide Quality oversight for enterprise GxP computerized systems. This position will help ensure that regulated digital platforms remain compliant, validated, reliable, and in a controlled state throughout their lifecycle.

A global biopharmaceutical organization is seeking a Senior Engineer to provide Quality oversight for enterprise GxP computerized systems. This position will help ensure that regulated digital platforms remain compliant, validated, reliable, and in a controlled state throughout their lifecycle.

The Senior Engineer will partner with Quality, Computer System Validation, IT, business, and vendor teams. The role requires someone who can interpret regulatory requirements, identify meaningful risk, and apply a practical validation strategy rather than relying only on checklists or standardized templates.

RESPONSIBILITIES

• Provide independent Quality oversight for GxP computerized systems from implementation through retirement.
• Review and approve validation plans, requirements, specifications, protocols, test evidence, and summary reports.
• Assess systems and system changes for patient safety, product quality, data integrity, and regulatory risk.
• Review change controls, deviations, corrective actions, periodic reviews, and related quality records.
• Apply risk-based validation principles to determine the appropriate level of testing and documentation.
• Evaluate electronic records, electronic signatures, audit trails, system access, and data integrity controls.
• Support supplier qualification, audits, inspection readiness, and cloud-based system implementations.
• Provide Quality guidance to technical, business, CSV, and vendor stakeholders.
• Support Quality oversight of AI and machine-learning-enabled GxP applications.

Role Requirements:

• Bachelor s degree in life sciences, computer science, engineering, or a related discipline.
• At least five years of QA or validation experience in an FDA-regulated pharmaceutical or biotechnology environment.
• Experience supporting GxP computerized systems throughout their lifecycle.
• Strong practical knowledge of 21 CFR Part 11.
• Strong practical knowledge of EU Annex 11.
• Experience reviewing or approving computerized system validation documentation.
• Working knowledge of GAMP 5 and risk-based validation.
• Understanding of FDA Computer Software Assurance principles.
• Experience with change control, deviations, CAPAs, and periodic system reviews.
• Knowledge of ALCOA+ and electronic data integrity expectations.
• Strong critical-thinking, documentation, and stakeholder communication skills.
• Ability to work onsite in Bridgewater 1 to 2 days per week.
• Ability to work through a W2 employment arrangement.
• Authorization to work in the United States without current or future employer sponsorship.

PREFERRED EXPERIENCE

• Experience with enterprise quality, regulatory, analytics, service management, or identity platforms.
• Experience with Veeva Vault or similar regulated enterprise platforms.
• Experience with SaaS and cloud-hosted GxP systems.
• Experience supporting regulatory inspections or audits.
• Familiarity with clinical or laboratory system validation.
• Exposure to Quality oversight for AI or machine-learning-enabled systems.
• Relevant Quality or software certification.

How We Work:

• We apply regulatory requirements thoughtfully and proportionally to risk.
• We expect Quality, technology, and business teams to work collaboratively.
• We communicate concerns clearly and support decisions with evidence.
• We focus on maintaining sustainable compliance throughout the system lifecycle.
• We value professionals who protect patient safety and data integrity without unnecessarily slowing delivery.