Process Development Engineer – Injectable Devices

Process Development Engineer – Injectable DevicesHybrid- (Perm or Contract) OverviewA great opportunity for a Process Development Engineer to support new product introduction and upstream manufacturing processes for injectable devices. This role combines hands-on process validation with cross-functional collaboration and continuous improvement within a regulated environment.

Key ResponsibilitiesSupport new product implementation (NPI), including process validation and risk managementAct as technical SME in technology transfer projectsDrive process improvements, efficiency gains, and cost reduction initiativesLead or support investigations into process deviations and anomaliesPerform root cause analyses and contribute to corrective actionsCollect and analyze data to support process monitoring and validationPrepare and review technical and regulatory-compliant documentationCollaborate with production, QA, regulatory, and development teamsRequirementsBSc or MSc in a relevant engineering discipline1–3 years’ experience in upstream manufacturing (biopharma or medical device preferred)Knowledge of GMP, process validation, and regulatory standardsExperience with root cause analysis and investigative methodologiesFamiliarity with sterilization processes is a plusStrong communication and documentation skillsFluent in EnglishWhat’s OfferedHybrid working model based in UppsalaA collaborative and cross-functional work environmentOpportunity to grow within process development and technical operationsInvolvement in meaningful product development projectsPlease apply if this is for you!!!!!!!!!!