Validation Manager - R&D Digital, Data & Informatics

  • Cambridge, Massachusetts
  • Work experience
  • Research, development, teaching
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Validation Manager - R&D Digital, Data & Informatics

Become Part of the BioNTech Family.

Based in Cambridge, MA, BioNTech US serves as BioNTech’s North American headquarters and is an important part of our global effort to pioneer the development of next-generation immuno-oncology therapies. BioNTech US is a fully integrated subsidiary 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.

We are seeking an experienced Validation Manager for our newly formed R&D Digital, Data & Informatics team. 


Here, you’ll achieve greatness.

Primary responsibilities include:
  • Responsible for the validation of Clinical Development systems and solutions
  • Transforms centrally-defined validation guidelines and policies to create a tailored plan for Clinical Development systems
  • Reviews CSV documents in accordance to standard operating procedures, regulatory requirements and guidelines; ensures timely resolution of documentation, compliance, and Clinical Development system issues
  • Creates validation report documents for Clinical Development solutions to ensure that all requirements are met
  • Supports independent continuous improvement of validation documentation and processes and supports implementation of improvements
  • Acts as the contact person for all validation issues, together with the relevant validation engineers for process and system owners, project management and SMEs; supports the audit process
  • Reviews and assists in investigating discrepancies/deviations
  • Supports change control assessments and reviews / approves change control implementation plans

What you have to offer.

  • Bachelor's degree in Computer Science, Mathematics, Information Systems, Medical, or Biomedical sciences 
  • Degree (or equivalent) in a science or (related engineering) discipline
  • 5+ years’ experience in validation / quality, ideally in the pharmaceutical industry
  • Knowledge in computerized system lifecycle activities, CSV and IT controls in a regulated environment
  • Knowledge of IT Control methodologies, including a solid understanding of GxP guidance
  • IT knowledge (access control, account setup, file permission, database knowledge, cloud knowledge)
  • Good understanding of validation principles and practices and a risk based approach
  • Knowledge on qualification and validation studies including working based on SOPs

Benefits for you.

BioNTech US is committed to the well being of our team members and offers a variety of benefits supporting our diverse employee base. 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, STD and LTD Insurance
  • HSA & FSA Spending Accounts
  • 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 subsidized parking
  • Discounted Home and Auto Insurance
  • Pet Insurance
Plus more benefits that will be shared upon hire!

Have we kindled your pioneering spirit?

Then apply now for our location Cambridge (Boston) and simply send us your application documents using our online form.

For those who require assistance due to disability, or have questions prior to applying, please email

*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!