- Gaithersburg, Maryland
- Work experience
- Production, manufacturing
- Quality Management, Quality Assurance
This position is based in Gaithersburg, MD at our newly formed research and clinical manufacturing site for BioNTech US. Together with the BioNTech US North American Headquarters in Cambridge, MA, both the Gaithersburg and Cambridge sites are an important part of our global effort to pioneer the development of next-generation immuno-oncology therapies that expects to experience significant growth in the near future. BioNTech US is a subsidiary of BioNTech SE with a strong foundation in Europe and a focus on the development of novel neoantigen-targeted T cell therapies, complementing BioNTech’s highly innovative scientific approach and diversified pipeline of transformative cancer medicines. As a key research and clinical development hub, BioNTech US will enable BioNTech’s growing presence in the US.
Under the supervision of the Director of Facilities and Engineering, this position will support the design, start-up, commissioning and qualification of Facilities, Engineering systems while leading a team of technical staff. This includes oversite of the engineering and maintenance of the building utilities, HVAC, control systems, equipment maintenance. The position will work closely with Engineering function while collaborating with the site’s Quality, Manufacturing, and Supply Chain units
Here, you’ll achieve greatness.
- Ensures that all facility utilities are 100% operational and maintained in support for production and laboratory activities
- Manage and perform maintenance staff routine maintenance tasks including HVAC, electrical and plumbing repairs, painting, office furniture installation, general building repairs, cleaning, building exteriors and other as assigned.
- Manage and organize maintenance employees work assignments while supporting maintenance work orders and preventative maintenance tasks.
- Ensure clean rooms and general facility are maintained in optimum conditions and in compliance with GMP requirements.
- Ensure manufacturing and all labs and lab personnel are supported to meet business needs, including lab gasses, preventive maintenance, equipment service contracts and safety equipment
- Recommend solutions and implements appropriate corrective action for major or complex maintenance issues using good documentation practices
- Maintain a safe work environment; work in a safe manner following all safety SOP’s and wear Personal Protective Equipment as required
- Establish and organize records keeping of maintenance activities according to cGMP
- Monitor and maintain contractors’ performance and work closely with outside vendors to ensure work is completed according to specifications.
- Ensure maintenance work orders are being completed on time while adhering to operational standards.
- Act as the point person to the facilities technicians while working closely to ensure strategic planning, implementations of plans, resolving problems while maintaining production quality.
- Participates in internal audit/inspection
- Compiles and reports technical performance metrics.
- Supports operational budget planning, long range planning and supports facility capital projects.
- Ensure compliance with all applicable regulatory agencies including FDA, OSHA, DOH, EPA, Fire Department, city audits, Health Department, etc.
What you have to offer.
Minimum requirements; Bachelor’s degree in engineering discipline or related field or equivalent experience, with 10+ years of facilities and maintenance operations experience in the biotechnology or pharmaceutical industry
- Experience with utilities, engineering, maintenance, computerized systems and validation activities in a GMP environment
- Experience with Computerized Maintenance Management Systems, and Building Management System.
- Experience work on mechanical, electrical, HVAC, boilers, water systems and compressed gases
- Have an understanding of quality systems; Change Control, Deviations, CAPA’s, and Audits activities.
- Skilled at creating and delivering presentations
- Able to check, respond, and troubleshoot Equipment Monitoring System & Building Management Systems issues and alarms.
- Able to work after hours and on call as needed; weekend shift support and shutdowns
- Be forward thinking the ability to work with system & technical metrics, identify variances & deficiencies while improving maintenance program and performance.
- Experience working on cross functional teams to obtain project deliverables
- Experience with systems investigation and root cause analysis tools
- Self-motivated with a strong sense of ownership in areas of responsibility
- Ability to adapt in a constantly evolving environment
- Ability to write department operational/maintenance and engineering SOP’s
- Self-starter with superior analysis and problem-solving skills ranging from simple to complex situations
- Proficient in MS Office suite
- Demonstrates proficiency in current Good Manufacturing Practices (GMPs).
- Excellent communications skills to explain information and influence others to secure successful implementation of Facilities and Engineering programs and directives as assigned.
- Able to build and manage a team as well as train entry-level personnel
- High energy level and a positive outlook coupled with the requisite “can do” attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles
- Willingness to think outside of the box and adapt best practices to our growing environment
Benefits for you.
- Medical, Dental and Vision Insurance
- Life, AD&D, STD and LTD Insurance
- HSA & FSA Spending Accounts
- Free COVID-19 Testing
- 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 free onsite parking
- Discounted Home and Auto Insurance
- Pet Insurance
Have we kindled your pioneering spirit?
For those who require assistance due to disability, or have questions prior to applying, please email email@example.com.
*BioNTech does not differentiate on the basis of gender, race or ethnicity, religion, color, sexual orientation or identity, disability, age and other protected statuses as given by applicable law. We are committed to creating a diverse environment and are proud to be an equal opportunity employer. Most important – it’s a match!