Computer System Validation Remote Jobs in Washington

Cambridge, US; Gaithersburg, US; New Jersey, US   |   full time   |   Job ID: 11216 

About the Role

As a Business Capability Specialist, you will serve as the critical link between our business stakeholders and the Data, Digital & Informatics (DDI) organization, ensuring that technology solutions seamlessly enable key business capabilities and support BioNTech's mission. Working closely with Medical Affairs (MA) and Medical Safety & Pharmacovigilance (MSPv) teams, you will help identify opportunities for digital transformation, translate business needs into scalable technology solutions, and ensure compliance with regulatory standards. By combining your technical expertise with a strong understanding of business processes, you will play an integral role in driving innovation, improving operational efficiency, and delivering measurable value across the organization.

Your Contribution

• Act as a trusted partner to Medical Affairs and MSPv teams to understand their needs and identify technology solutions aligned with BioNTech's strategic goals
• Analyze current business processes, identify gaps, and propose innovative digital solutions to enhance efficiency and effectiveness
• Lead or support the planning, prioritization, implementation, and operational management of technology projects within GxP environments
• Collaborate with cross-functional teams to develop process documentation (as-is/to-be), system requirements, functional specifications, and testing protocols
• Support technology roadmap development by working closely with Business Partners and portfolio management teams
• Partner with vendors to implement new technology solutions while ensuring seamless integration into existing systems
• Troubleshoot operational issues and ensure systems meet regulatory and validation requirements (e.g., 21 CFR Part 11, EMA Annex 11)
• Support GxP Computer System Validation activities by creating key documentation such as Validation Plans, User Requirements Specifications (URS), Testing Protocols (IQ/OQ/PQ/UAT), Traceability Matrices, and Validation Summary Reports
• Collaborate with procurement, legal, finance, quality partners, and other stakeholders on contracts and operational processes for quality systems

A Good Match

• Bachelor's degree in Computer Science, Mathematics, Information Systems, or Life Sciences-related fields
• 5+ years of experience as a Business Analyst within the Life Sciences industry; experience supporting Medical Affairs or MSPv is highly preferred
• Deep understanding of R&D business processes and data management within pharmaceutical settings
• Strong knowledge of technologies and trends in the pharmaceutical industry; experience supporting digital platforms commonly used in Global Development organizations is a plus
• Expertise in business process mapping efforts (as-is/to-be), gap analysis methodologies, project management principles, and leading international project teams
• Familiarity with GxP guidelines (e.g., 21 CFR Part 11) and Computer System Validation processes
• Exceptional analytical skills combined with a proactive mindset to solve complex problems collaboratively
• Superb interpersonal skills with an ability to engage effectively across diverse teams

Expected Pay Range:  $113,600/year to $181,600/year + benefits, annual bonus & equity (bonus and equity is variable and dependent on company and individual performance).  *Compensation for the role will depend on several factors, including responsibilities of the job, education, experience, knowledge, skills, and abilities.

Your Benefits:

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.
 

Home to dozens of research institutions, biopharmaceutical companies, life science incubators, venture capital firms, and over 30 million square feet of laboratory space, Cambridge, Massachusetts has earned a reputation as the #1 life science cluster in the world. As part of the Greater Boston area, the city is often referred to as the "biotech supercluster" due to its high concentration of life sciences firms. This unique ecosystem is the result of a model partnership between academia and industry, fostering collaboration and innovation and driving the development of new therapies, medical devices, and diagnostics. As Cambridge's thriving life sciences industry continues to evolve, the city remains a beacon of knowledge, innovation, and collaboration, poised to shape the future of science and technology.

Apply now - We look forward to your application!

Apply for our Cambridge, US; Gaithersburg, US; New Jersey, US location and simply send us your documents using our online form.

By submitting your application, you acknowledge that a background check will be conducted as part of the recruitment process in accordance with applicable laws and regulations. If you are considered for the position, BioNTech will conduct the background check through our service provider 'HireRight'. You will be informed accordingly by your BioNTech-Recruiter.