Outside Service Manager*
- 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 manage all the Outside Vendor management for our Manufacturing and Laboratories Operations.
Here, you’ll achieve greatness.
- Ensures that all facility equipment is 100% operational and maintained in support for production and laboratory activities
- Lead teams that resolve and repair equipment failures safely and expeditiously
- Oversee the installation, calibration, troubleshooting, repair, and modification to process instruments or systems, which support manufacturing and laboratories operations.
- Schedules the daily activities of all Outside Vendors for the maintenance, repair, calibration of equipment and/or mechanical, electrical systems in respective area of responsibility, ensuring that Standard Operating Procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements are followed.
- Maintain accurate equipment and systems record keeping of maintenance activities according to cGMP
- at all times
- Procures spare parts, labor, special tools, calibration equipment, contracts, documentation and equipment availability for work execution.
- Carefully reviews completed schedules and corresponding work orders returned by the maintenance area supervisors, monitors work order progress, and prepares associated reports.
- Act as the point person to the Instrumentation & calibration technicians while working closely with the manager to ensure strategic planning, implementations of plans, resolving problems while maintaining production quality.
- Support the qualification and / or validation of facilities equipment.
- Assist in the selection and monitor the performance of outside contractors and vendors
- Maintain a safe work environment; work in a safe manner following all safety SOP’s and wear Personal Protective Equipment as required
- 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 in pharmaceutical and/or biopharmaceutical industry facility ramp up and equipment layout, installation and calibration.
- Experience with utilities, engineering, maintenance, computerized systems and validation activities in a GMP environment
- Experience work on mechanical, electrical, HVAC, boilers, water systems and compressed gases
- Experience with Computerized Maintenance Management Systems, and Building Management System.
- Have an understanding of quality systems; Change Control, Deviations, CAPA’s, and Audits activities.
- 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
- Working knowledge of scientific and engineering principles
- Skilled at creating and delivering presentations
- 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
- 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!