Biontech SE Gaithersburg , MD 20877
Posted 3 weeks ago
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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.
Director, Facilities (BSS) & Engineering
Responsibilities
Provide oversight to the Facility Maintenance, Calibration, Capital Expense, Validation, Automation, and Security programs for the assigned site
Responsible for leading the development of the utility and equipment risk framework and process for the site
Responsible for delivering end to end maintenance and calibration process improvements as well as leading the organization in identification and implementation of a world class maintenance program
Collaborates with Manufacturing and Quality teams to ensure equipment and facility remains available for use and does not impact the ability to deliver projects and products
Assumes overall accountability for the management of building, equipment, and grounds
Responsible to maintain and support continuity of GMP manufacturing operations in a reliable, efficient and compliant manner.
Responsible for site facility business continuity and critical systems redundancy, 24/7 support model and site resiliency/recovery plan
Accountable for site capex portfolio management and successful capex project delivery
Accountable for developing and delivering the Gaithersburg Site sustainability roadmap
Administer the organization that will manage the maintenance of the manufacturing envelope as well as the uptime of the critical manufacturing and QC equipment
Accountable for staff development, budgeting and cost control, talent mapping, succession planning, the development of strong leaders within the function, and multifunction long-term planning
Coordinate the activities of department management and provide direction and assistance on resolution of complex issues, compliance issues and potential problems related to production planning and material management
Provides compliance with respect to scheduled Planned Maintenance and calibrations
Ensures Computerized Maintenance Management System remains current
Maintain relevant files, drawings, and records required for a GMP operation
Manage capital and non-capital projects to improve capacity, quality, efficiency, utilization and EHS
Responsible for capital plan and forecasting as well as departmental budget
Responsible for projects to maximize output, minimize cost and support efficiencies and improve EHS performance
Maintain collaboration with Corporate Facilities and Engineering as well as the global and regional F&E networks
Evaluates the best practices amongst the internal network and external resources
Consults and cooperate with site/ business unit / corporate / supplier personnel as
authorized and required, maintaining effective communications, and working relations
Ensures a relevant knowledge base in place to best manage programs with respect to governing cGMP regulations, requirements of city, state and federal permitting and environmental agencies as it relates to the business
Serves as a member of the Site Leadership Team and demonstrate ownership of the business unit goals and objectives.
Requirements
BS degree in Engineering and minimum of 12+ years of relevant experience in cGMP manufacturing, facility maintenance experience in the biotechnology or pharmaceutical industry and/or prior industrial maintenance experience involving mechanical, electrical and electronics in a cGMP regulated environment
We will ask you to develop solutions to highly complex problems which require an in-depth degree of ingenuity, creativity, and innovation
Proven experience with site capital portfolio management and capital project delivery
Enterprise leadership and strategic mindset within function and at a global/business level
Excellent and effective global stakeholder management experience
Demonstrates the ability to deal across several multi-national agencies, sites, and organizations
Strong computer and organizational skills required. Project management experience required.
Experience and knowledge on GMPs and supporting GMP manufacturing operations
Working knowledge of automation control, alert and data collection/retention systems
Working knowledge of HVAC and clean utility systems
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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 Development Programs
Commuting Allowance and subsidized parking
Discounted Home, Auto & Pet Insurance
…and more! More details to be shared.
BioNTech is an equal opportunity employer and complies with all applicable federal, state, and local fair employment practices laws. BioNTech does not tolerate discrimination against employees or applicants because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including gender, pregnancy, sexual orientation, and gender identity), age, physical or mental disability, citizenship, past, current, or prospective service in the uniformed services, genetic information, or any other characteristic protected under applicable federal, state, or local law.
If you are unable or limited in your ability to use or access BioNTech's online application tools due to a disability, you can request reasonable accommodations by calling 1-857-228-6231or by e-mailing jobs@biontech.de. Thank you for your interest in BioNTech.
Biontech SE