lead engineer

·      Bachelor’s Degree in Process Engineering, or a related discipline.

·      At least 3 years of experience in Commissioning and Qualification.

·      Knowledge of technical advanced machines (fully automated), vision systems, infrastructure and other relevant areas within operations.

·      Knowledge with pharmaceutical and medical device industry requirements (cGMPs, 21 CFR Part 11, GAMP5).

·      Great communication skills

·      Strong in coordination and well structured

·      Critical thinker with problem-solving skills.

·      Team player.

·      Proficient in English and Swedish.

·      Responsible to lead and drive project and test related to commissioning and qualification activities concerning the Packaging Line 7 and 9 including it’s hardware for the serialization system from SEA Vision.

·      Work according to developed plans, qualification test protocols, traceability matrices, reports, IQ/OQ/PQ (Installation Qualification/Operational Qualification/Performance Qualification) protocols, and other relevant documents.

·      Ensures proper technical documentation delivered by the supplier fulfill the assigned URS and identifies associated unit and deployment testing.

·      Maintains test plans, test scripts, and user acceptance tests.

·      Executes activities from the validation plans and related documents.

·      Cross functional coordination between suppliers and work streams regarding commissioning and qualification

·      Plan and participate in supplier verification activities (FAT, SAT, Line SAT)

·      Attend meetings regarding components and component design needed to be adjusted from a process perspective.

·      Support Junior Eengineers when needed

·      Target for work to deliver a fully functional machine line executed in an approved PQ/PPQ