Mainz, Germany | full time | Job ID: 9383
As global Manufacturing,Science & Technology we establish and maintain reliable commercial manufacturing processes. The Validation Manager in the Global Manufacturing Science and Technology Validation group is responsible for supporting or (co-)leading validation activities within BioNTech's global manufacturing operations including especially external manufacturing. This role ensures that all manufacturing and/ or cleaning processes are validated according to regulatory requirements and industry best practices, contributing to the consistent production of high-quality pharmaceutical products.
Responsibilities:
* Develop and implement global validation strategies, policies, and procedures to ensure compliance with regulatory requirements (e.g., FDA, EMA) and industry standards, including process, cleaning, and continued process validation.
* Support validation projects for new and existing manufacturing processes, including the review and, in some cases, preparation of validation plans, protocols, and reports.
* Participate in or lead improvement, troubleshooting, and problem-solving efforts related to validation issues.
* Support regulatory filings and internal or external inspections/audits as a validation Subject Matter Expert (SME).
* Provide training and guidance to team members and other departments on validation principles and practices.
Requirements:
* Bachelor’s degree or higher in Pharmacy, Chemistry, or a related field.
* At least 3 years of experience in validation (in one or all of the following: process validation, cleaning validation, OPV/ CPV) within the pharmaceutical industry.
* In-depth knowledge of regulatory requirements (e.g., FDA, EMA) and industry standards in validation.
* Experience in the manufacture of biologics, proteins, monoclonal antibodies, ADCs or mRNA drug substance and/ or drug product is an advantage
* Strong project management skills and ability to collaborate across teams.
* Excellent communication skills in English, German is a plus
* Ability to analyze complex problems and develop practical solutions.
* Proven skill to work in a dynamic work environment
* Detail-oriented, excellent problem-solving skills, and critical thinking abilities
Your Benefits:
It's our priority to support you:
* Your flexibility: flexible hours | vacation account
* Your growth: Digital Learning | Performance & talent development | leadership development | Apprenticeships | LinkedIn Learning
* Your value: Your voice at the table | Culture on an equal footing | Opportunities to shape & impact | Support for your full potential
* Your health and lifestyle: Company bike
* Your mobility: Job ticket | Deutschlandticket
* Your life phases: Employer-funded pension | Childcare
Apply now - We look forward to your application!
Apply to our Mainz, Germany location by sending us your documents via our online form. For any questions, contact our talent acquisition team on: + 49 (0) 6131-9084-1291 (Monday-Friday from 12 PM to 4 PM CET).
Job ID 9383 (please always specify if you have any questions)
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.