Development Quality Engineer
Newark Metro Area, NJ
The Development Quality Engineer is responsible for providing sound technical support and expertise to product development and lifecycle management teams to increase overall product quality and compliance. The development Quality 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 position 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 in support of regulatory submissions. In this role, the Development Quality Engineer will own Design History File deliverables, author development documentation strategies, facilitate risk analyses and provide general technical engineering support throughout new product development and lifecycle projects.
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 ensuring compliance with company procedures and external regulations.
- Participates on teams to ensure robust application of appropriate controls in the design, development, qualification and commercialization phase of product development.
- Supports application of company policies and processes in collaboration with external manufacturers, CMOs and CROs.
- 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.
- Knowledge of drug substance, drug product, primary containers, container closure systems and drug delivery devices.
- An understanding 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.
- Knowledge 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.
- College or University degree required. Degree focus areas include engineering, material science and physical/natural science. Minimum 1-3 years relevant work experience, specifically in the healthcare space (Pharmaceutics, Biopharmaceutics and Medical Devices).