Nadja Schultz Jensen

Senior Consultant

Summary

Experienced in vaccine production, adjuvants, insulin, and antibiotics. Known for driving process improvements, documentation excellence, and cross-functional collaboration in regulated pharma environments.
Earlier in my career, I worked as a researcher in Denmark,
Germany, and Singapore, focusing on microbial fermentation, enzyme immobilization, and bioprocess development. This foundation strengthens my ability to bridge science and production in complex pharma environments.

Special Competences

Project management
Project leader for numerous smaller improvement initiatives, with proven ability to drive progress and deliver results. Work Package Owner in large-scale, cross-functional pharmaceutical projects.
Cleaning Validation
Responsible for planning, execution, re-validation and verification of cleaning processes, including audit readiness and implementation of improvements within constrained operational frameworks.
Quality & GMP documentation & Risk Management
Proficient in deviation handling, change control, CAPA, SOP, WFI batch documentation & Risk assessments (FMECA, EHS) & experienced in supporting audits and maintaining GMP compliance in daily operations.
Qualification/Validation & Comissioning
Skilled in preparing and executing qualification and validation in accordance with EU (EudraLex) and US (FDA) standards & worked with Commissioning documentation: RTM, OQ, DQ, FAT, SAT, IQ
Process Technology & Unit Operations
Broad experience with processes/equipment such as fermenters, centrifuges, CIP systems, cross flow filtration, freeze drying, ion exchange chromatography, aseptic filling machines, autoclaves, and purified water systems
Training & Knowledge Transfer
Responsible for training operators, QC, and support staff

Project Experience

Specialist – Xellia A/S – 2023/2025

Cleaning Validation specialist.
- Solely responsible for Cleaning Validation, site CPH
Responsible for improvement projects.
- Implementation of Artificial Instant Review (AI tool) of cleaning enclosures
- Implementation of ethanol wipes to aseptic filling line
- Observation on the airlock, aseptic filling area
- Prolongation of conveyor belt of washing machine, aseptic filling area

Quality Engineer – AFRY – 2021/2023

Automation: Documentation for Qualification – and Validation & Commissioning
- Xellia A/S: Review of initial validation of DeltaV
- Lundbeck A/S: Flammefældesystemer HLU El-rådgivning og automation til 5 flammefælder
Cleaning Validation, Bavarian Nordic A/S
- EnRa-project, CV of new Ultra Centrifuges, Tech Transfer, Rabies & TBE

Academic – AJ Vaccines – 2019/2021

Responsible for support of media & eluent preparation, polio vaccines production
Responsible/Project participant for improvement projects
- Filing 1 project, investment project, Polio vaccine factory
- Participating in CAPEX project to improve the deviation flow

Process Specialist – Croda – 2017/2018

Responsible for support to the adjuvant production: Quil-A, Adjuphos & Alhydrogel
Responsible for improvement projects
- Responsible for stability study of Quil-A (adjuvant)
- Implementation of an alternative process for the entrance control of containers (aseptic filling of adjuvants)
- Implementation of a novel CIP procedure for tubings used in production

EM Support – Novo Nordisk A/S – 2014/2017