Senior Validation Engineer — Lead GMP Validation & Compliance

AstraZeneca; Rockville (MD); On-site; USD 130,000 - 170,000; Full time

Job summary

AstraZeneca in Rockville, MD is seeking a trusted validation engineer to influence projects from concept through operational release. You will partner across Manufacturing, Laboratory, Facilities, Quality, Engineering, MS&T, and IT to strengthen quality, innovation, and compliance.

You will lead validation strategies, direct protocol planning, and champion data integrity and 21 CFR Part 11 while guiding cGMP across facilities, equipment, and systems.

Qualifications

• 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.

Responsibilities

• Lead 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.

Skills

Bachelor’s degree in Engineering or a

Education

Bachelor’s degree in Engineering (preferred)

Tools

Veeva Vault

SAP

Blue Mountain

Paperless validation

Job description

AstraZeneca in Rockville, MD is seeking a trusted validation engineer to influence projects from concept through operational release. You will partner across Manufacturing, Laboratory, Facilities, Quality, Engineering, MS&T, and IT to strengthen quality, innovation, and compliance.

You will lead validation strategies, direct protocol planning, and champion data integrity and 21 CFR Part 11 while guiding cGMP across facilities, equipment, and systems.