At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe. As a Technology Engineer in Gaithersburg, MD, you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives.
Technology Engineer position available in Gaithersburg, MD to support Global Engineering computerized systems validation for capital projects within the Operations Department. Perform computerized systems validation in connection with laboratory projects, as well as pharmaceutical and biological manufacturing processes. Perform computer validation planning and execution. Apply Good Manufacturing Practices (GMP) and Good Automated Manufacturing Practices (GAMP). Identify and recommend approaches to improve the efficiency of computerized systems and equipment delivery. Prepare resource loaded plans for project delivery. Deliver computerized systems validation elements within project cost and schedule. Ensure computerized systems validation factors into the project planning phase. Provide automated pharmaceutical equipment/systems and supporting documentation in accordance with the requirements from international government agencies and latest industry practices. Ensure that the equipment/system meets performance criteria, including product quality, patient safety and integrity of data. Provide subject matter expertise to high business impact engineering projects, particularly involving construction of new or major expansion of both pharmaceutical manufacturing capabilities as well as scientific research and development. Provide technical analysis throughout design, implementation and testing phases of the project to identify any potential risks, gaps and non-compliances of the automated pharmaceutical equipment/systems that can adversely affect product quality and patient safety. Provide assessments of the pharmaceutical equipment/systems suppliers to ensure suitability of their products and services. Ensure compliance with government requirements, corporate procedures, and industry practices. Provide support for government inspections of pharmaceutical equipment/systems. Provide improvements for existing technologies and methods that can successfully benefit business, product quality and patient safety. Position requires a Master's degree or foreign equivalent in Engineering (any), or a related field plus one (1) year experience in the job offered, or as a Computer Validation Expert; IT Specialist; or a related position. Must have one (1) year of experience in the pharmaceutical/medical industry working in automation or computerized systems validation: maintaining compliance with International pharmaceutical industry standards and regulations, including GAMP, FDA Code of Federal Regulations (CFR), EU GMP Guidelines and UK Medicines and Healthcare products Regulatory Agency (MHRA) Guidelines; integrating Distributed Control (DCS) Systems; deploying Supervisory Control and Data Acquisition (SCADA) systems and Building Automation (BAS) systems; developing secured data historian systems for data collection and archiving; developing process automation strategy, and performing design implementation and quality testing for packaging, production and inspection lines, cleaning and sterilizing equipment, analytical laboratory systems and equipment; developing and implementing secured data networks, including server virtualization platforms; designing and implementing SQL databases; generating engineering design drawings in CAD systems; providing user training and support or IT and automation systems; and performing supplier auditing. M-F, 40 hrs/wk. EOE.
Requisition Number: 17-C1003.
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A little about us:
MedImmune is the global biologics research and development arm of AstraZeneca