Tobias Schneider

Lead Engineering Compliance @ BioNTech SE

About

I am an engineering and compliance leader with progressive experience in GMP-regulated biopharmaceutical manufacturing, combining technical depth with organizational leadership across quality-critical engineering functions. My background spans engineering compliance, asset lifecycle management, maintenance and calibration, commissioning and qualification, deviation and CAPA governance, training and hygiene oversight, computerized systems validation, and inspection readiness. Over the course of my career at BioNTech, I have led teams and organizations supporting complex manufacturing and infrastructure environments, with responsibility for regulated assets, engineering governance, technical performance, and cross-functional compliance execution. In my current role, I lead an engineering compliance organization covering Maintenance & Calibration, Commissioning & Qualification, Deviation & CAPA Management, and Training & Hygiene in a GMP-regulated manufacturing environment. My focus is on building robust governance structures, strengthening KPI and escalation frameworks, enabling inspection readiness, and supporting reliable and compliant operations across manufacturing and QC-related areas. I am particularly motivated by roles at the intersection of technical operations, quality, and leadership — where strong governance, capable teams, and cross-functional collaboration are critical to sustained performance in regulated environments. Core areas of expertise include: • Engineering Compliance Leadership • Asset Lifecycle Management • GMP Manufacturing Support • Maintenance & Calibration • Commissioning & Qualification • Deviation & CAPA Governance • Inspection Readiness • Computerized Systems Validation • Data Integrity / ALCOA+ • FDA / EU GMP / SHE requirements • Technical Governance and KPI Management • Cross-Functional Leadership in Biopharma Operations I am always interested in connecting with professionals working in biopharma manufacturing, engineering leadership, quality systems, and technical operations.

Country

Germany

City

Marburg an der Lahn

Industry

Biotechnology

Skill

Asset Lifecycle Management, Management Engineering, Engineering Leadership, Veränderungsmanagement, compliance, gmp , Zwischenmenschliche Führung, Technische Führung, Führung , Künstliche Intelligenz (KI), Prozessautomatierung, Data Engineering, Statistische Datenanalyse, Datenbankverwaltung, Datenbanken , Datenbanksicherheit, Datenbanken, Data Science, CMMS, Validation

Experience

Lead Engineering Compliance

BioNTech SE

2026-4 - Present · 6 mos

Marburg an der Lahn

Manager - Engineering: • Commissioning & Qualification • Maintenance & Calibration Management • Operational hygiene and compliance Management • Deviation and CAPA Management • Technical Documentation Lead - Technology & Infrastructure Workstream | Site Transformation Project: • Transforming a single-product site into an advanced multi-product facility for late-stage clinical mRNA manufacturing

Head Asset Life Cycle Management

BioNTech SE

2023-3 - 2026-3 · 3 yrs 1 mo

Marburg an der Lahn

Manager - Engineering: • Maintenance & Calibration Management • Technical Documentation Lead - Technology & Infrastructure Workstream | Site Transformation Project: • Transforming a single-product site into an advanced multi-product facility for late-stage clinical mRNA manufacturing

Lead Production Systems Engineering

BioNTech SE

2021-3 - 2023-3 · 2 yrs 1 mo

Marburg, Hessen, Deutschland

Manager - Engineering: • Plant Maintenance • Calibration Management • Asset Management • Data Platform / Historian • Technical Documentation

Qualification Manager

BioNTech SE

2020-12 - 2022-7 · 1 yr 8 mos

Marburg, Hessen, Deutschland

eQMS: Qualification responsible for the integration of a new quality management system.

Engineering Project Lead

BioNTech SE

2020-11 - 2022-7 · 1 yr 9 mos

Marburg, Hessen, Deutschland

Engineering Project Lead: • Integration Workstream (ERP Site Integration) • Segregation Workstream (Product ramp down)

Bachelor thesis supervisor and examiner

BioNTech SE

2021-1 - 2021-5 · 5 mos

Marburg, Hessen, Deutschland

Supervisor and examiner for the bachelor thesis "Applied validation strategies using an example of a continued process verification for pharmaceutical process equipment"

Automation Engineer -Data Engineering

BioNTech SE

2020-11 - 2021-3 · 5 mos

Marburg, Hessen, Deutschland

• Automation: Vertical integration projects • Data Engineering: Digital Transformation projects Process Historian & Process/Product Analytics related projects & integration Administration & Maintenance of the PI-System (Data Management for industrial operations)

Project-Lead: Continuous Process Verification (CPV)

BioNTech SE

2020-11 - 2021-3 · 5 mos

Marburg, Hessen, Deutschland

• Design and implementation of a continuous process verification system with OSIsoft PI-System based on advanced analytics to ensure the FDA stage 3 requirement for process validation lifecycle.

Engineering Project Lead

Novartis

2020-9 - 2020-11 · 3 mos

Marburg, Hessen, Deutschland

Engineering Project Lead: • Segregation Workstream • Integration Workstream

Project: Continuous Process Verification (CPV)

Novartis

2019-2 - 2020-11 · 1 yr 10 mos

Deutschland

• Design and implementation of a continuous process verification system with OSIsoft PI-System based on advanced analytics to ensure the FDA stage 3 requirement for process validation lifecycle.

Automation Engineer

Novartis

2018-10 - 2020-11 · 2 yrs 2 mos

Marburg

• Automation: vertical integration projects • OSIsoft Pi-System related projects & integration • Administration & Maintenance of the Pi-System • Batch Reports Design & Administration (Rt Reports) • Client Software related internal Training

Digital Champion - Digital Transformation Biotech DS

Novartis

2020-1 - 2020-10 · 10 mos

Marburg

• Defining key initatives and local road maps regarding the digital transformation. • Vertical coordination of digital transformation workstreams and projects.

SPOC - Data Integrity (ENG)

Novartis

2020-5 - 2020-9 · 5 mos

• Support of data integrity assessments • Ambassador of data integrity for the engineering department

Subject-matter expert

Novartis

2017-7 - 2018-10 · 1 yr 4 mos

Marburg, Hessen, Deutschland

Via Zenith Technologies OSIsoft Pi System: • Batch Reports Design & Administration (Rt Reports) • Pi-System Administration & Maintenance

Automation Specialist

GSK

2015-3 - 2018-10 · 3 yrs 8 mos

Frankfurt Am Main Area, Germany

OSIsoft Pi System: • 1st Level Support and troubleshooting of the Pi System • Administration & Maintenance of the Pi System • Batch Reports Design & Administration (Rt Reports) • Client Software related internal Training Emerson DeltaV: • Full managed services / continuous integration • Recipe design for batch production • Support of the complete Software Change Life Cycle • Server Health and Performance Monitoring Trackwise - Sparta Systems: Sentry Change Control • Evaluations & Implementation

Automation Engineer

Novartis

2014-5 - 2015-3 · 11 mos

Frankfurt Am Main Area, Germany

Emerson DeltaV: • Full managed services / Continous integration • Support of the complete Software Change Life Cycle • User-Management • Server Health and Performance Monitoring

Automation Engineer

Cognizant Life Sciences Manufacturing

2014-3 - 2014-5 · 3 mos

Irland - Cork

Pharma industry: Emerson DeltaV • Testing of Control and Equipment Modules (CMs, EMs) against Test Specifications • Changing Test Specifications • Code changes with Client Change Requests • Organizing hand over documentation for a project

Student - Research & Development: Simulation

Bosch

2012-10 - 2013-7 · 10 mos

Lollar

Pre-thesis industrial practical and Diploma thesis

Student job - Pharma industry: Production

Engelhard

2010-11 - 2011-8 · 10 mos

Frankfurt Am Main Area, Germany

• Monitoring of the production process • Correction of defects • Changing over the production units for new batch • Documentation of the production after batch

Skilled manual worker for mechatronics

Siemens

2006-2 - 2006-8 · 7 mos

Frankfurt Am Main Area, Germany

• Electrical and mechanical build-up of medium voltage systems (up to 40kV) • Instruct staff & supervising production line • Final inspection, testing & shipping approval