Validation Engineer

Job DescriptionATTRACTIVE SKILLS/EXPERIENCES:Bachelor’s Degree in Mechanical, Electrical, Pharmaceutical or Materials Engineering (required)MS Degree and/or Six Sigma Certifications (preferred)Experience (4+ years) of relevant Mechanical/Process Engineering in a Manufacturing EnvironmentProficiency with statistical software (Minitab; JMP)Proficiency with design software (SolidWorks; CAD; AutoCAD)Proven knowledge of cGMP and ISO Standards (9001; 15378)Proven knowledge/usage of MS Office applicationsExperience in pharmaceutical or glass forming industry (preferred)Demonstrated communication skills (written / oral) including the ability to read/speak EnglishAbility and willingness to work in fast-paced, matrix structured organizationSUMMARY / RESPONSIBILITIES: This Manufacturing Engineer II (sterile) will propose, lead, plan, direct and implement major projects involving technical systems. Projects include continuous improvement, production introduction, risk management, process development, design and installation of equipment, sustainability of processes and equipment. Moreover, help to satisfy department goals and objectives. Other potential duties/expectations include (but not limited to)…Lead process mapping and continuous improvement activities of production lineProvide statistical analysis of processesParticipate in engineering/production functions to achieve objectivesLead/support engineering activities regarding the innovation, design, purchase, fabrication, installation, start-up, and validation of production machinery and processes (URS / Risk Assessment / IOPQ/PV / Change Control)Perform root cause analysis of customer complaints and associated CAPAsEstablish operating procedures and maintenance requirementsLead experimental and validation protocols for equipment, processes, and materialsSupport product portfolio activities including feasibility, specification changes and introduction of productsPropose projects for cost reductions, feasibility studies, facility layout, and equipment modifications; scope and define projects to meet cost, quality and performance requirementsAssist in innovation, design, and process development serving as plant key contact and manufacturing expertDefine and develop control strategies and systems for automated manufacturing equipmentMentor (instruct/train) Engineering Techs and Process Engineers in formal troubleshooting and best known methods, when applicableApply Project Management tools to coordinate and implement CAPEX & Equipment/Product related projectsFollow cGMP and adhere to all ISO and safety guidelines and policiesPerform other duties as assigned