Engineering Support Specialist
101 Orchard Ridge Drive North Potomac, MD 20878 US
Target Pay Rate: 35-47.85/hr **salary will be commensurate with experience
Summary of the group:
Device Development provides combination product expertise to the development of drug-delivery parenteral for the expanding Astra Zeneca pipeline. We are seeking an Engineering Support Specialist to join the Device Functionality and Safety team and support teams daily workstream. The group consists of people with diverse scientific and engineering backgrounds and work experience. The team primarily leads and implements characterization, evaluation, and design verification of various combination devices and novel technologies and provides technical support in multifunctional drug product programs. Tooling design, fixture prototyping, fluidic dynamics simulation, and management of contract testing services are within the scope of work. The Engineering Support Specialist is responsible for successful completion of assigned tasks before due time independently or under minimal supervision, from experimental design, method development, drafting of protocols and SOPs, to execution of the study, data collection and analysis, and creation of technical report. All work shall meet quality and regulatory compliance standards and guidance.
Main Duties & Responsibilities: The candidate will be responsible for the following activities:
- Facilitate maintenance, upgrading, and validation of Container Closure Integrity (CCI) testing systems
- Develop and maintain good relationship with vendors and contract labs, request quote, submit purchase orders, and keep tracking of ongoing studies
- Design, develop and execute experiments (DOE) for CCI method development and qualification
- Perform routine device characterization and verification tests following the SOPs and protocols
- Make detailed observation, analyze data, interpret results, maintain documentation, and prepare technical summaries and reports with minimum to no supervision
- Deliver timely, high-quality data interpretation and summary reports to drive key scientific decision and provide technical support and troubleshooting
- Being creative in method development, technology innovation and adoption of newer technologies to meet challenges
- Master the skills of using device testing equipment and associated software such as the tensile test machine (INSTRON), dye ingress, high voltage leak detection (HVLD), mass extraction, vacuum decay
- Standardize the operational procedures and minimize the human error and variation
- Facilitate method transfer to GMP testing group
- Establish and foster a strong collaborative working relationship with internal functions, stakeholders, opinion leaders and external vendors/suppliers.
- Comply with appropriate quality and regulatory standards, e.g. USP/PharmEur, ISO/MDD/GMP, 21CFR Part 4, 11, & 820.30 and applicable safety requirements
Education & Experience Requirements:
B.S. or M.S. degree in Engineering, Pharmacy, Pharmaceutical Sciences, or related field. Required Skills:
- 2+ year experience of working on prefilled syringes, autoinjectors, cartridges, or other types of drug delivery devices in the biotech or pharmaceutical company
- 1+ year experience with container closure systems, product packages, combination products and related stability/QC/release testing
- Hands on experience with CCI testing and method development and qualification for dye ingress, HVLD, mass extraction, vacuum decay, among others.
- Experience with design, execution and interpretation of tests and experiments
- Knowledge of statistical data analysis using Minitab or similar
- Experience with good document practice
- Strong communication and influence skills and detail-oriented
- Experience with Instron or similar electromechanical testing equipment
- Knowledge and experience of 3D modeling software, system control software and fluidic dynamics simulation software such as Solidworks, LabVIEW, Matlab, COMSOL, etc.
- Knowledge of medical device verification & validation is a plus.
- Knowledge of global industry standards and guidance (ISO, USP, AAMI, ANSI, ASTM, etc) applicable to drug administration device and combination product is desired.
- A track record of working effectively within a matrix organization with a highly cross-functional and collaborative environment is desired.
- Strong work habits and commitment to the position are highly valued.
- Problem solving and creativity are also fundamental qualities for this role.
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