Experienced deviation writer

About NalysNalys 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 DescriptionWe 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 & ResponsibilitiesLead and write detailed deviation investigations for aseptic manufacturing operationsCollaborate with operators, supervisors, engineering, and QA to collect data, identify root causes, and define effective CAPAsEnsure investigation reports are scientifically sound, well-documented, and completed within defined timelinesReview process trends and identify opportunities for continuous improvement and deviation reductionSupport implementation of CAPAs and verify their effectiveness on the manufacturing floorProvide guidance to manufacturing staff on best practices for deviation documentation and GMP complianceSupport preparation for internal and regulatory inspections related to deviation investigations.Profile / RequirementsYour ProfileYou hold a Master's degree in a scientific or engineering discipline (e.g., Microbiology, Biotechnology, Pharmacy, Chemical Engineering) or equivalent experienceYou have a minimum of 5 years of experience in GMP manufacturing, with at least 2 years focused on aseptic or sterile operationsYou demonstrate an experience in writing or supporting deviation investigations within a manufacturing environmentYou have a strong understanding of aseptic techniques, contamination control, and cleanroom operationsYou have excellent technical writing, analytical, and communication skillsYou are able to work independently and collaboratively in a fast-paced, regulated environment.The Recruitment ProcessBy Applying To The Position Of "Experienced Deviation Writer", Here Are The Steps You Will Follow During The Recruitment ProcessOlivia Braszko, Talent Acquisition Specialist, will review your application and schedule a first screeningFor the second interview, you will meet our Technical Director, Alexandre Yvankovich for a deeper discussionA final interview will be held with our Business Unit Director, Jimmy Rousseaux.