Senior Validation Enginner

AstraZeneca plc; Durham (NC); Presencial; USD 120 000 - 160 000; Tempo integral

Resumo da oferta

AstraZeneca plc is seeking a trusted validation engineer to influence projects from concept through release and to collaborate across Manufacturing, Laboratories, Facilities, Quality, Engineering, MS&T, and IT. You will lead validation lifecycle deliverables, ensure regulatory compliance, and drive continuous improvement across GxP systems.

Essential qualifications include seven years in validated environments, CQV/CSV experience, and strong knowledge of GMP, data integrity, and regulatory

Qualificações

• Minimum seven years of validation experience in a regulated pharmaceutical, biotechnology, or GMP environment.
• Experience with CSV throughout the system lifecycle and CQV for GMP equipment, utilities, facilities, or manufacturing systems.
• Strong working knowledge of GMP and GDP requirements, ISPE GAMP 5, risk-based validation, data integrity, 21 CFR Part 11, EU GMP Annex 1, change control and CAPA systems, DQ/IQ/OQ/PQ lifecycle, and Validation Master Plans.
• Proven ability to author, review, and approve validation documentation.
• Desirable experience with cell therapy, biologics, sterile manufacturing, MES, ERP, LIMS, SCADA, BMS, or related GxP platforms.

Responsabilidades

• Lead validation strategies and lifecycle deliverables translating risk and regulatory expectations into clear plans and defensible conclusions.
• Coordinate qualification and continued control of GMP facilities, utilities, equipment, and manufacturing systems.
• Direct protocol planning, execution, and integration of commissioning, calibration, and maintenance evidence.
• Support CSV across the full system lifecycle with rigorous requirements, risk assessments, testing, and traceability.
• Provide forward-looking validation impact assessments for software upgrades and infrastructure changes.
• Represent validation during audits, inspections, and customer reviews with inspection-ready documentation.
• Develop procedures, templates, and risk-based practices to improve governance and efficiency.

Conhecimentos

Validation experience

CQV

CSV lifecycle

GMP/GDP knowledge

Data integrity

CAPA/change control

Audits/regulatory

Formação académica

Bachelor's degree in Engineering or related

Ferramentas

Veeva Vault

SAP

LIMS

SCADA

Descrição da oferta de emprego

As a trusted validation engineer, you will influence projects from concept through operational release, partner across Manufacturing, Laboratory, Facilities, Quality, Engineering, MS&T, and IT, and help build a culture in which quality, innovation, and compliance strengthen one another.

Typical Accountabilities

• Lead/coordinate validation strategies and lifecycle deliverables that translate risk, regulatory expectations, and business needs into clear plans, robust testing, traceability, and defensible conclusions.
• Guide the qualification and continued control of GMP facilities, utilities, equipment, temperature-controlled storage units, manufacturing systems, and laboratory equipment that support dependable operations.
• Direct protocol planning and execution, evaluate installations and changes, and integrate commissioning, calibration, maintenance, and engineering evidence into sound qualification decisions.
• Support CSV across the full system lifecycle, developing rigorous requirements, specifications, risk assessments, testing, traceability, and summary documentation for GxP systems.
• Provide forward-looking validation impact assessments for software upgrades, patches, infrastructure changes, periodic reviews, and lifecycle maintenance, ensuring systems remain fit for intended use.
• Champion cGMP, data integrity, 21 CFR Part 11, EU GMP Annex 1, GAMP 5, site procedures, and company validation standards through practical, risk-based application.
• Lead and support deviations, CAPAs, change controls, and investigations, using disciplined root-cause analysis and effectiveness verification to convert issues into lasting improvement.
• Represent validation with confidence during internal audits, regulatory inspections, and customer audits, supported by accurate, complete, and inspection-ready documentation.
• Elevate the validation program by developing procedures, templates, standards, and risk-based practices that improve consistency, efficiency, and lifecycle governance.
• Bring cross-functional teams together around clear priorities, realistic schedules, transparent status, and proactive risk mitigation across Engineering, Manufacturing, Quality, Facilities, MS&T, and IT.
• Grow organizational capability by coaching project teams and less-experienced validation colleagues, sharing knowledge, and modeling strong technical judgment and quality leadership.

Qualifications and Skills

Essential:

• Bachelor’s degree in Engineering (preferred), Computer Science, Biotechnology, or a related technical discipline;
• minimum seven years of validation experience in a regulated pharmaceutical, biotechnology, medical-device, or comparable GMP environment;
• demonstrated experience with CQV for GMP equipment, utilities, facilities, or manufacturing systems;
• experience supporting CSV throughout the system lifecycle; and a strong record of authoring, reviewing, and approving validation documentation.
• Strong working knowledge of GMP and GDP requirements, ISPE GAMP 5, risk-based validation, data integrity, 21 CFR Part 11, EU GMP Annex 1, change control and CAPA systems, the DQ/IQ/OQ/PQ lifecycle, Validation Master Plans, and validation maintenance programs.

Desirable:

• Experience supporting cell therapy (clinical/commercial stages), biologics, or sterile manufacturing; MES, ERP, LIMS, SCADA, BMS, EMS, laboratory computerized systems, or similar GxP platforms;
• Veeva Vault, SAP, paperless validation systems, Blue Mountain, or equivalent systems;
• temperature mapping, cleanroom and utilities qualification, environmental monitoring systems, and cross-functional project leadership.

Date Posted

16-Oct-2026

Closing Date

30-Oct-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.