System Engineer, Production Systems

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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.

 

 

System Engineer, Production Systems 

 

BioNTech currently runs a variety of digitalization projects including SAP ERP, MES and LIMS systems. The Senior System Engineer is part of the team that drives the digitalization roadmap for computer systems.

The System Engineer, Production Systems is part of the team that builds, deploys, and runs our digital solutions. The Senior Engineer will act as an IT Business Partner.  With a high level of technical domain expertise in regulated production applications which digitalize processes in the pharmaceutical and biopharmaceutical industry, the Engineer will work cross-functionally through the application and project life cycle to ensure consistent processes delivered according to our standards and across the application landscape.


Primary responsibilities include:

 

• Bring in domain expertise in production systems as well as market knowledge in the area of MES, LIMS, SAP/ERP, Label Management, and other production system applications.
• Support the system landscape in close alignment with process owners, system architects and portfolio/project managers.
• Act as administrator for various applications.
• Configure software solutions based on user requirements; develop scripts and guide software developers for extensions and interfaces.
• Ensures successful delivery of projects (installations, integrations, upgrades, etc).
• Engage and cooperate with internal customers, business process owners, as well as external partners, suppliers and/or vendors.
• Participation in the strategic approach and roadmap for the digital landscape, including validation support.

Requirements:

• Minimum of 7 years of experience managing applications in the biotech or pharmaceutical industry.
• Experience working under cGXP in the life sciences, pharma, or medical device sectors, including computer systems validation.
• Knowledge of and experience with systems used in the production environment (e.g. ERP, MES, LIMS, Label Management, etc.)
• Strong process thinking and understanding, quick comprehension, flexible and organized.

 

Preferred Requirements:  Experience with international peer collaboration. Experience in a production environment.

 

Benefits for you:

BioNTech US is committed to employee wellbeing and offers best-in-class benefits & HR programs to support an inclusive & diverse workforce. 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, Critical Illness Insurance
• Pre-tax HSA & FSA, DCRA Spending Accounts
• Employee Assistance & Concierge Program (EAP) available 24/7
• Parental and Childbirth Leave & Family Planning Assistance
• Sitterstream: Virtual Tutoring & Childcare Membership
• Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
• 401(K) Plan with Company Match
• Tuition Reimbursement & Student Loan Assistance Programs
• Wellbeing Incentive Platforms & Incentives
• Professional Develop