About us
About Nalys
Nalys is a fast-growing consultancy company specialized in high-tech engineering and life sciences. We partner with leading organizations to deliver innovative solutions and expert support across a wide range of technical domains. At Nalys, we combine deep expertise with a human-centric approach — empowering our consultants to thrive and our clients to succeed. Joining Nalys means becoming part of a collaborative, agile, and forward-thinking team that values excellence, innovation, and continuous growth.
Job Description
We are looking for an experienced professional to lead and author investigations related to manufacturing deviations within aseptic and sterile production environments. This role is critical to ensuring compliance with GMP standards and driving continuous improvement in manufacturing processes.
The Role & Responsibilities
Lead and write detailed deviation investigations for aseptic manufacturing operations
Collaborate with operators, supervisors, engineering, and QA to collect data, identify root causes, and define effective CAPAs
Ensure investigation reports are scientifically sound, well-documented, and completed within defined timelines
Review process trends and identify opportunities for continuous improvement and deviation reduction
Support implementation of CAPAs and verify their effectiveness on the manufacturing floor
Provide guidance to manufacturing staff on best practices for deviation documentation and GMP compliance
Support preparation for internal and regulatory inspections related to deviation investigations.
Required qualifications
Your Profile
You hold a Master's degree in a scientific or engineering discipline (e.g., Microbiology, Biotechnology, Pharmacy, Chemical Engineering) or equivalent experience
You have a minimum of 5 years of experience in GMP manufacturing, with at least 2 years focused on aseptic or sterile operations
You demonstrate an experience in writing or supporting deviation investigations within a manufacturing environment
You have a strong understanding of aseptic techniques, contamination control, and cleanroom operations
You have excellent technical writing, analytical, and communication skills
You are able to work independently and collaboratively in a fast-paced, regulated environment.
The Recruitment Process
By applying to the position of "Experienced deviation writer", here are the steps you will follow during the recruitment process :
Olivia Braszko, Talent Acquisition Specialist, will review your application and schedule a first screening
For the second interview, you will meet our Technical Director, Alexandre Yvankovich for a deeper discussion
A final interview will be held with our Business Unit Director, Jimmy Rousseaux.
