Senior Manager, Cloud Development Operations Engineer

Company: BioNTech IMFS
Location: Cambridge
Posted on: September 20, 2023

Job Description:

Press Tab to Move to Skip to Content Link Become a member of the BioNTech Family! Based in Cambridge, MA and Gaithersburg, MD. We are committed to improving the health of people worldwide with our fundamental research and our work in the area of development of immunotherapies utilizing the full potential of the immune system to fight cancer, infectious diseases and other serious diseases. We believe in scientific rigor, innovation and passion as driving forces. BioNTech was founded by scientists and physicians to translate science into survival by combining fundamental research and operational excellence. With decades of deep immunology expertise and experience in developing and optimizing mRNA as part of its broad suite of novel technologies, the company is working with the global community to defeat life-threatening and serious diseases such as cancer, COVID-19, malaria and tuberculosis. The first ever approved mRNA vaccine was created in the labs of BioNTech in Mainz, Germany. A fully integrated immunotherapy powerhouse. We remain focused on bringing our broad pipeline of next-generation immunotherapies and vaccines to people around the world to address cancer, infectious diseases, as well as a growing list of other medical conditions. To accomplish this, we continue to be deeply rooted in science and academic research while also having built a fully integrated, global immunotherapy company with cGMP and GMP manufacturing facilities anchored around deep expertise in immunology and complemented by an expanding set of capabilities.
- Senior Manager, Process Automation Engineer We are seeking an experienced -Senior Manager, Process Automation Engineer for our R&D Digital, Data & Informatics team! Responsibilities include: Analyze and evaluate existing clinical processes and workflows to identify opportunities for automation, process improvement, and compliance enhancement within the GxP framework. Collaborate with stakeholders, including clinical operations, quality assurance, and technology teams, to understand automation requirements and translate them into technical solutions compliant with GxP regulations. Revise and interpret demand to ensure definition of ready and done are clearly defined to support development of automation demands. Design, develop, and implement automation workflows, scripts, and applications using a variety of automation technologies Collaborate with our validation team to ensure all automation solutions are validated and compliant with GxP regulations, including 21 CFR Part 11, EU Annex 11, and other relevant standards. Conduct risk assessments and impact analyses for automation solutions, addressing potential risks and implementing appropriate controls and safeguards. Collaborate with quality assurance teams to develop and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for automation systems. Configure, test, and deploy automation solutions, ensuring seamless integration with existing clinical systems, electronic data capture (EDC) platforms, and other relevant applications while maintaining data integrity and traceability. Requirements include: Bachelor's degree in Computer science, engineering, life sciences (or a related field) and at least 7-10 years of relevant experience. Proven experience in process automation within the pharmaceutical or clinical research industry, specifically in a GxP-regulated environment. Strong proficiency in automation tools and technologies, such as RPA platforms (e.g., UiPath, Automation Anywhere), ChatBot frameworks (e.g., IBM Watson, Microsoft Azure Bot Services, RASA), Document Understanding tools (e.g., UiPath, Abbyy, Google Cloud Document AI), Testing automation solutions (e.g. UiPath Testing, Selenium) and Process Mining software (e.g., Celonis, UiPath Process Mining). Proficient in programming languages and scripting, such as Python, Java, or PowerShell, to develop automation solutions and facilitate integration with GxP systems. Relevant certifications in process automation technologies are highly desirable.

Benefits for you:
- BioNTech US -is committed to the well being of our team members and offers a variety of benefits supporting our diverse employee base. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to: Medical, Dental and Vision Insurance Life, AD&D, STD and LTD Insurance Health & Wellness, including free onsite gym access Adoption & Surrogacy Assistance Vacation and Unlimited Sick Time Holidays and Floating Holidays, including discretionary winter shutdown 401(K) Plan with Significant Company Match Tuition Reimbursement and Professional Development Commuting Assistance and subsidized parking Discounted Home and Auto Insurance Pet Insurance Plus more benefits that will be shared upon hire! Have we kindled your pioneering spirit? -
- Then apply now for our location -Cambridge (Boston) -and simply send us your application documents using our online form.

*BioNTech does not differentiate on the basis of gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important - it's a match!
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Keywords: BioNTech IMFS, Cambridge , Senior Manager, Cloud Development Operations Engineer, Engineering , Cambridge, Massachusetts