Innovative Drug Delivery Systems Expert Wanted

1 week ago

Dublin, Dublin City, Ireland beBeeMedicalDeviceEngineer Full time €90,000 - €120,000

Are you a highly skilled Medical Device Engineer looking for a new challenge? Azurity Pharmaceuticals is seeking an experienced professional to join our team and contribute to the development of cutting-edge drug delivery systems. In this role, you will collaborate with multidisciplinary teams to design and develop high-quality combination products that enhance patient outcomes around the world.

Key Responsibilities:

  • Documentation:
    • Author and maintain comprehensive documentation, including Design Development and Verification Plans, Design Inputs/Outputs and User Requirements Specifications (URS), Risk Management Documentation (ISO 14971), and Conformity Assessments and DHF (Design History File) management.
  • Project Execution:
    • Successfully develop state-of-the-art drug delivery systems (e.g., respiratory, nasal, parenteral) with high quality standards in strict timelines and budget.
  • Regulatory Compliance:
    • Apply regulatory standards to ensure designs meet global compliance requirements, including ISO 13485, ISO 14971, 21 CFR 820, and 21 CFR.
    • Owner of the section related to Container-Closure-System and drug-product characterization of regulatory submissions.
  • Communication and Collaboration:
    • Liaise with external and internal stakeholders to gather necessary information and ensure smooth communication.
    • Work closely with R&D, Legal, Quality, Regulatory, and manufacturing teams throughout development and coordinate necessary approvals.
  • Lead third parties for development and commercial supply:
    • Choose external vendors based on expertise, timelines, and cost, while negotiating quotes, service agreements and contracts.
    • Develop components using soft and/or multi-cavity tools and validate processes while introducing acceptance testing for individual and assembled parts.

Prerequisites:

  • University degree in Engineering or Biomedical, or a related scientific field.
  • 5+ years of experience in drug delivery device development.
  • Proven expertise in regulated environments under cGxP, QSR, or equivalent.
  • In-depth knowledge of combination product regulations and industry practices.
  • Knowledge of drug delivery devices (respiratory, nasal, parenteral), risk assessment, tolerance analysis, statistical techniques, process capability, manufacturing processes, transportation studies, and validation.
  • Experience with Health Authority interactions is a plus.
  • A working knowledge and practical experience with device development and manufacturing operations activities for drug/device systems in a cGMP environment.
  • Skills:
    • Strong organizational skills with attention to detail.
    • Excellent written documents and verbal presentation skills.
    • Proficiency in CAD, CFD, FEA, X-ray/CT scan.
    • Ability to work independently and as part of a team.

Why Join Us?

  • Opportunity to work with a leading pharmaceutical company.
  • Collaborative and supportive work environment.
  • Career growth and development opportunities.

Work Schedule:

  • Hybrid position based in Dublin/Zug with in-office days on Tuesday, Wednesday, and Thursday.

  • Innovative Drug Delivery Systems Engineer

    1 week ago

    Dublin, Dublin City, Ireland beBeeMedical Full time €60,000 - €70,000

    Azurity Pharmaceuticals is a pioneering specialty pharmaceutical company dedicated to delivering innovative products that cater to the needs of underserved patients. Our commitment to quality and accessibility has enabled us to establish ourselves as an industry leader in providing unique, high-quality medications that have benefited millions of patients...

  • Inhalation Drug Delivery Specialist

    1 week ago

    Dublin, Dublin City, Ireland beBeeResearch Full time €49,397 - €63,558

    Postdoctoral Researcher Job DescriptionWe are seeking a highly motivated and experienced researcher to join our team as a Postdoctoral Researcher. This role is an exciting opportunity for a talented individual to contribute to the development of novel inhalable antifibrotic treatments for idiopathic pulmonary fibrosis and related interstitial lung...

  • Grocery Key Account Manager

    5 days ago

    Dublin, Dublin City, Ireland United Drug Full time

    Direct message the job poster from United DrugTalent Acquisition Specialist | PHX IrelandOur people make the difference. Here at PHX Ireland, we strive to be a place for everyone - where each and every one of us can be our true, authentic selves, every single day.For us, individuality sparks new ideas, shapes new approaches and brings us powerful new...

  • Grocery Key Account Manager

    6 days ago

    Dublin, Dublin City, Ireland United Drug Sangers Full time

    OverviewJoin to apply for the Grocery Key Account Manager role at United DrugDirect message the job poster from United DrugWhat You'll Be Doing:Account Management: Develop and maintain strong relationships with key grocery partners, ensuring high levels of customer service and satisfaction.Sales Strategy: Create and implement effective sales strategies to...

  • Senior Technical Lead

    3 days ago

    Dublin, Dublin City, Ireland beBeeManufacturing Full time €100,000 - €120,000

    We are seeking a Senior Technical Lead to spearhead the drug product new product introduction (NPI) and lifecycle management (LCM) technical delivery team.Reporting directly to the Director of Process Development, this key role will oversee a team of subject matter experts covering the main aspects of drug product manufacturing process including NPI/LCM and...

  • Associate Director, Medical Innovative Contracting

    4 days ago

    Dublin, Dublin City, Ireland Optum Full time

    OverviewOptum is a global organisation that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they need to feel their best. Here, you will find a culture guided by diversity and...

  • Senior Medical Youth Drug and Alcohol Specialist

    2 weeks ago

    Dublin, Dublin City, Ireland beBeeCareWorker Full time €42,000 - €63,000

    Job Title: Senior Medical Youth Drug and Alcohol WorkerThis position is a senior-level role within our organization's drug and alcohol services department. The successful candidate will be responsible for leading and managing the delivery of high-quality youth-focused interventions.The ideal candidate will have extensive experience in working with young...

  • Leading Validation Expert for Sterile Drug Products

    2 weeks ago

    Dublin, Dublin City, Ireland beBeevalidation Full time €90,000 - €120,000

    Senior Validation EngineerWe are seeking an experienced and skilled professional to join our team as a Senior Validation Engineer. In this role, you will contribute to the Sterile Drug Product Facility project, serving as an integral member of the Commissioning, Qualification, and Validation (CQV) team.Your key responsibilities will include creating and...

  • Chief Drug Product Manufacturing Specialist

    18 hours ago

    Dublin, Dublin City, Ireland beBeeEngineering Full time €50,000 - €60,000

    Project Engineer Job OpportunityAbout the Role:This is a fantastic chance to work with an international Biotechnology company in Dun Laoghaire, Dublin.Key Responsibilities:Support manufacturing at various contract manufacturing sites across Europe.Develop as a drug product technical expert, providing leadership and solutions for parenteral drug product...

  • Procurement Systems Manager I

    2 weeks ago

    Dublin, Dublin City, Ireland Cadence Design Systems Full time

    OverviewAt Cadence, we hire and develop leaders and innovators who want to make an impact on the world of technology. Cadence is a pivotal leader in electronic design, building upon more than 30 years of computational software expertise. The company applies its underlying Intelligent System Design strategy to deliver software, hardware and IP that turn...