Packaging Engineering Project Specialist III

**Work Schedule**Standard (Mon-Fri)**Environmental Conditions**Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)**Job Description****Summary:**Support/Lead client packaging development projects from initial design to ongoing commercial production.**Essential****Functions:**LeadtheProjectManagement forimplementationofprojectspecificpackagingequipment, new market launches andserialization requirements where applicable.WorkwithGlobalSerializationteamandoutsideVendorstocoordinatechangestoSerializationsystems.Contributetothedevelopment ofRiskAssessments,Packaging Engineering LineTrialprotocols/ reportsand Packaging Master Batch Records.Participateinthedevelopmentofclientpackagingserializationrequirements.SupportqualificationofERPsystemsrelatedtoserialization.Supportcoordinationandexecutionofengineeringlinetrialsthatinvolvescomponents,scheduling, training, documentation, serialization, etc.ManagecompletionofequipmentCorrectiveAction PreventativeActions(CAPA''s).Supportimplementationofimprovementsintobatchrecords.Liaisewithfunctionalareas(includingclientsandvendors)tomeetprojectobjectives.Participateincontinuousimprovementactivitiesasneeded.Maintainasafeworkingenvironmentandreportpotentialhazards.Performalternatingorrotatingshiftworkasrequired.**REQUIRED****QUALIFICATIONS****Education:**College/Technical School diploma in relevant technical field.**Experience****:**Minimum 3 years of previous related experience and general knowledge of a drug packaging, validation or packaging production.Experience in packaging technical/scientific discussions with clients. Previous Project Management experience an asset.**Equivalency:**Equivalent combinations of education, training, and relevant work experience may be considered.**Knowledge,****Skills****and****Abilities:**General understanding of drug packaging processes and sterilization. Good Manufacturing Practices, Standard Operating Procedures and Food and Drug Administration (FDA) compliance knowledge. Demonstrates organizational skills relevant to drug packaging. Strong technical writing and oral presentation skills. General knowledge of experimental design. General understanding of drug product validation and communication. Ability to recommend improvements relating to pharmaceutical packaging, equipment, processes and systems. Actively acquires new skills/knowledge relevant to the drug packaging process. Draws on experience and demonstrates innovative approach. Works autonomously under general direction to meet project and team objectives. Established quality, regulatory, and production mentalityincludingan appreciationforclientserviceand thecontractmanufacturing industry. Demonstrated computer proficiency with Microsoft Office programs. Proficiency with the English language.**Knowledge,****Skills****and****Abilities:**Extensive knowledge and understanding of drug packaging processes as well as drug product validation and commercialization processes. Demonstrates organizational skills relevant to drug packaging. Strong written and oral communication skills. Extensive knowledge and experience with experimental design. Detail oriented and organized, with a high degree of accuracy and thoroughness.Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.