New · posted Oct 19
AstraZeneca · Pharmaceuticals
Senior Validation Engineer
- Rockville, MD
- On-site
- Full-time
- Senior & Principal
Closes Oct 31, 2026 · 11 days left
The role
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.
What you need
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.
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.
Where you'll work
Rockville, MDOn-siteOpen in Maps (opens in a new tab)
More jobs in Rockville, MDJob intelligence
The context around this role
Live data · October 20, 2026
Salary intelligence
How the pay compares
Senior & Principal roles in the US49 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $105,500 | $119,500 | $130,000 |
Comparisons: the base pay employers published on open Validation & CQV roles at the same level on Regulatory Jobs, October 20, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Validation & CQV
The general path across 117 open Validation & CQV roles on Regulatory Jobs, with the titles they carry most. Not AstraZeneca's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 23 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Validation and qualification15
- GMP and compliance9
- Data and digital systems6
- Lab testing and methods5
- Documentation and SOPs5
- Collaboration and leadership5
- Quality systems and risk3
- Investigations and CAPA2
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- European CommissionEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules and annexes
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
AstraZeneca on Regulatory Jobs
- 17
- Open roles
- 14
- Distinct roles
- 7
- Locations
By discipline
- Regulatory10 59%
- Quality7 41%
By level
- Director9 53%
- Associate & Specialist4 24%
- Manager2 12%
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Senior Validation Engineer at AstraZeneca
Applications close October 31.