Celgene Device Development Engineer - Drug Delivery Systems in Summit, New Jersey
Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Device Development Engineer - Drug Delivery SystemsSummit, NJ
PURPOSE AND SCOPE OF POSITION:
Reporting to the Head of Device Engineering, the Device Development Engineer is responsible for providing sound technical support and expertise to product development and lifecycle management teams in support of device and combination product development. The Device Development Engineer supports the compliant development of new products through participation in cross functional product teams and ensuring process conformance to global standards and regulations. This role will participate in the design and development of new and novel combination products in collaboration with external partners and will have responsibility for the creation and accuracy of developmental documentation, ensuring the integrity and accuracy of data from feasibility studies through process development and final process characterization. Additionally, the Device Development Engineer will lead experiments and perform physical device characterization studies including human factors in collaboration with small and large molecule formulation development teams.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities
Introductory knowledge of drug substance, drug product, primary containers, container closure systems and drug delivery devices.
Introductory knowledge of end-to-end device and combination product design attributes including: packaging, sterilization, biocompatibility, drug-device compatibility and fill/finish.
General knowledge of the regulatory and compliance requirements for design controls and combination products (21 CFR Part 4, 21 CFR Part 820, ISO 13485 and ISO 14971, 93/42/EEC).
Awareness of pharmaceutical and biologic regulations and standards including 21 CFR Part 210, 21 CFR part 600, 2010/83/EC and relevant ICH guidelines.
Experience with the use/implementation of Risk Management and statistical analysis tools (e.g. Six Sigma, Risk Analysis, FMEA, etc.)
Ability to identify problems, review related information, develop and evaluate options, and implement solutions
Skilled oral and written communicator
Ability to work in a cross-functional, matrixed environment.
Intermediate level knowledge of standard office productivity tools (MS Office, Adobe, Project, Visio, etc.)
Must be comfortable working in a dynamic and highly innovative environment.
Experience in a laboratory environment including knowledge of standard environmental health and safety practices and regulations.
DUTIES AND RESPONSIBILITIES
Serves as development representative for design control including specification development, requirements flow-down, design verification, design validation, process development and design transfer on assigned product development teams.
Participates on teams to ensure robust application of appropriate controls in the design, development, qualification and commercialization phase of product development.
Support requirements definition, design and qualification of components and finished assemblies in collaboration with external manufacturers.
Provides ongoing engineering support throughout the product lifecycle focusing on risk management, design and manufacturing changes, and design-driven investigations.
Leads Risk Management activities on product development teams and owns the final Risk Management Report (RMR).
Provides SME guidance to development teams on topics related to developmental documentation, data accuracy, data integrity and good documentation practices.
Engages in continuous improvement activities by identifying opportunities and recommending improvements to design and development process.
Applies scientific theories and technical principles to solve problems of moderate complexity with minimal oversight.
Performs physical device characterization studies and experiments in support of feasibility, verification, validation and human factors.
Builds and maintains strong collaborative partnerships with external manufacturers, clinical researchers and academic institutions engaged in the development of novel combination products and technologies.
EDUCATION AND EXPERIENCE
College or University degree required. Degree focus areas include engineering (mechanical, biomedical and systems), material science and physical/natural science. Minimum 1-3 years relevant work experience, specifically in the healthcare space (Pharmaceutics, Biopharmaceutics and Medical Devices).
WORKING CONDITIONS: (US Only)
Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated, but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.