Senior Manager, Cloud Development Operations Engineer
Company: BioNTech IMFS
Location: Cambridge
Posted on: September 20, 2023
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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
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