Jobs / United States / Astrazeneca Pharmaceuticals Lp
Device Assembly Process Engineer
Astrazeneca Pharmaceuticals Lp · 🇺🇸 US - Gaithersburg - MD
Sponsorship verdict
Sponsorship possible
One solid signal, not two — worth applying, and worth asking about sponsorship early.
- Employer is on a government sponsor recordThe US Department of Labor certified 99 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest Jun 2026) — the step every H-1B hire needs first. USCIS also records 31 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
- The posting doesn’t mention sponsorshipSilence isn’t a refusal — ask the recruiter before investing much time.
- No salary bar for this routeH-1B has no fixed salary bar: the employer must pay at least the prevailing wage for the role and area. Cap-subject employers enter a lottery weighted by wage level. Source: https://www.federalregister.gov/documents/2025/12/29/2025-23853/weighted-selection-process-for-registrants-and-petitioners-seeking-to-file-cap-subject-h-1b, rules effective 2026-02-27.
- What Astrazeneca Pharmaceuticals Lp paid sponsored hires in similar roles2 certified filings for “Senior Platform Engineer - CRM Applications” (Information Technology Project Managers) in DE: $149k–$176k, median $163k. Most were filed at wage level III (50%) — 3 lottery entries, ≈46% projected selection odds for cap-subject employers. Source: US Department of Labor LCA disclosure data (Oct 2025 – Jun 2026).
- Confirmed live todayWhen a source last listed this job as open.
US H-1B: cap-subject employers enter a lottery weighted by wage level — Level I gets 1 entry, Level IV gets 4 (DHS projected selection odds ≈15% at Level I to ≈61% at Level IV). Universities and non-profit research employers are cap-exempt. The $100,000 fee for new petitions from abroad is currently blocked by a court order (appeal pending).
A verdict summarises public evidence; it is not legal advice and never a guarantee — the employer and the immigration authority decide. Sign in to factor in where you can already work.
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Sponsor Radar — Astrazeneca Pharmaceuticals Lp
The US Department of Labor certified 99 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest Jun 2026) — the step every H-1B hire needs first. USCIS also records 31 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
Past sponsorship or register membership never guarantees sponsorship for this vacancy or for you. Full Sponsor Radar for Astrazeneca Pharmaceuticals Lp →
About the role
The candidate will support assembly process development for medical devices and/or combination products, which may include accessorized prefilled syringes, auto-injectors, and/or other devices. Primary responsibilities will include: 1) Device/Combination Product Assembly Technical Leadership: Give to the operation of a fill-finish/assembly pilot laboratory with lab scale capabilities including vial and syringe filling, lyophilization, and device assembly. Develop risk assessment tools, study protocols and report templates. Provide technical rigor in experimental design and data analysis across projects. Carry out ongoing academic, regulatory and vendor literature review, maintain groundbreaking technical knowledge, and communicate findings to team 2) Assembly Process Characterization: Perform risk analyses and conduct laboratory or engineering studies to characterize processes. Test, analyze and interpret a range of assembly methods on device or combination product performance (e.g. injection time, glide force). Design process steps, establish associated operational design space and control strategy. Support engineering and Clinical/Commercial GMP runs at assembly sites. Review and approve batch records, validation protocols, and other GMP documents. Provide on-site support for assembly activities and support to close non-conformances. Support Regulatory writing for clinical and commercial filings. 3) Medical Device/Combination Product Design Transfer: Assist or lead late-stage and commercial design transfer of assembly processes to CMOs and internal facilities for parenteral biopharmaceutical or synthetic drug products (including technical support for clinical technology transfer as required). Organize an internal sending unit team including development functions (formulation, process, device, analytical, packaging), operations, supply chain, project management and QA. Manage timelines and activities internally, communicate goals and track work you're doing at the receiving site. Manage DT documentation optimally. Some travel is required (typically 1 – 2 trips per year) in the US and abroad. Education & Experience: • Educational requirements include a degree in Mechanical Engineering, Biomedical or related engineering or pharmaceutical science field. • Bachelors degree and 5+ years OR Master's degree and 2+ years of med device or combination product experience. The candidate should have capability, skill and/or knowledge in most of the following areas: • Biopharmaceutical / combination drug product development • Combination product and cGMP regulations • Assembly, label and packaging processes and equipment • Validation of Equipment, Process and Shipping Configurations • QbD, experimental design, statistics, data analysis • Leadership and interpersonal communication • Technical writing and documentation Experience: Suitable experience may include development of combination products and/or associated manufacturing processes, Quality oversight or validation of device/combination product assembly processes. Design Transfer experience or experience organizing and leading multi-functional teams is valuable. Knowledge of injection molding and materials science of polymers is helpful. A high degree of self-motivation, mechanical skill and technical rigor is required. Strong communication and technical writing skills are important. Though this position is in Development, we will consider strong candidates with GMP process development experience, e.g. in technical services or validation. We will also consider strong candidates from a device development or small molecule parenteral background. Why AstraZeneca? At AstraZeneca, we accept change and seize opportunities to innovate. Delivering life-changing medi