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AstraZeneca · 3 days ago

Engineering Technician

Durham, NC

Full-time

Onsite

New Grad, Entry Level

0+ years exp

AstraZeneca is a leading company in the pharmaceutical industry, focused on innovative processes and quality compliance. The Engineering Technician role involves supporting cGMP manufacturing operations and providing technical guidance while ensuring process integrity and regulatory excellence.

BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Set up, operate, clean, and maintain manufacturing equipment and precision instruments for inhaled and OSD unit operations to ensure optimal performance, reliability, and cGMP compliance

Support end-to-end execution of development and clinical batches, including material dispensing, line clearance, in-process controls, sampling for release/testing, and complete, accurate batch documentation

Provide technical support to team members and engineers, troubleshooting standard issues using existing knowledge and seeking information as needed; coordinate readiness of equipment, utilities, and tooling for development and clinical campaigns

Create, revise, and manage SOPs, batch records, training materials, engineering work instructions, and other cGMP documentation; draft analysis to support business cases, improvement plans, investigation reports, and performance recommendations

Own or support CAPAs, Change Controls, and Deviations; participate in investigations and root-cause analyses to maintain process quality and regulatory adherence; ensure compliance with Safety, Health, Engineering, cGMP, and site standards

Plan, lead, and execute preventive and routine maintenance; maintain equipment records and calibration status; contribute to resource planning and allocation to meet production and project schedules

Provide input to continuous improvement activities; support new product introduction, scale-up, and tech transfer learnings for inhaled and OSD processes; identify and implement operational excellence opportunities

Participate across the PT&E function to ensure priorities are executed and projects deliver to plan; contribute to development of resource plans, risk assessments, and readiness reviews for inhaled and OSD batches

Introduce process and equipment improvements; contribute to value-driven innovation aligned with global engineering standards and best practices

Qualification

CGMP manufacturing experienceEngineering degreeSOP managementCAPA/deviation/change controlRoot-cause analysisTechnical supportPreventive maintenanceProcess improvementPlanningCoordinationInnovation

Required

Bachelor's Degree in Engineering (Mechanical, Chemical, Biomedical, or related)

0-3 years of industry experience

Preferred

Working towards a professional qualification

Experience supporting cGMP manufacturing operations (inhaled and/or OSD) for development/clinical batches

Ability to follow SOPs and maintain accurate documentation

Experience with CAPA/deviation/change control

Familiarity with root-cause analysis and continuous improvement methodologies

Company

AstraZeneca

Glassdoor4.1

AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.

Founded in 1999

Cambridge, Cambridgeshire, GBR

10001+ employees

https://www.astrazeneca.com

H1B Sponsorship

AstraZeneca has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2021 (2)

2020 (11)