TOLMAR Inc. Validation Engineer III in Windsor, Colorado
Purpose and ScopeResponsible for the development and execution of qualification activitiesincluding, design, installation, operational and performancequalification for manufacturing supportfacilities/utilities/systems/equipment (FUSE).Essential Duties & Responsibilities Responsible for the change management for validated processes andequipment. Supports development of validation programs/processes for Validationdepartment. Generates and maintains site and project Validation Plans. Updates, leads, and executes FUSE re-qualification schedules/activities. Schedules and coordinates Qualification activities with cross-functionalteams. Supports cross-functional teams in FUSE procurement and requirements. Generates protocols and executes qualification activities for thefollowing FUSE;o Temperature controlled environments (Warehouse, Stability Chambers,Incubators, Freezers, Water baths, Refrigerators, Hot boxes, etc.)o Injectable aseptic manufacturing equipment (Fillers, Wetmill, BulkTanks, etc.)o Dermatological manufacturing equipment (Mixers, Tanks, Fillers,Homogenizers, etc.)o Utilities (WFI, Purified (USP), DI, Clean Steam, etc.)o Laboratory equipment (HPLC, TOC, Laminar Flow Hoods, BSC, etc.)o Sterilization equipment (Autoclaves, Dry Heat Ovens, Steam in Place(SIP), Isolators, etc.)o Cleaning equipment (Clean in Place (CIP), Parts Washer) Reviews and approves cycle development initiatives and activities. Support cleaning and process development/commercial activities. Interface with Engineering, Facilities, Regulatory, andManufacturing personnel as needed. Perform other related duties as assigned.Requirements Knowledge, Skills & Abilities Effective organization and project management skills. Effective troubleshooting and problem solving skills. Proven skills in leading major Validation projects. Ability to maintain gowning requirements as needed to access controlledareas. Ability to lead multiple projects simultaneously. Ability to work both independently and in conjunction with a team. Develop and implement creative solutions to problems. Proficient knowledge with MS Office. Proficient knowledge of GMP regulations and validation guidelines. Proficient knowledge and experience in writing protocols and followingprocedures. Experienced with validation tools such as Kaye Validator. Excellent oral and written communication skills demonstrated throughinteractions internally and externally. A valid driver s license and acceptable motor vehicle record required. Ability to train junior associates in validation principles.Education & Experience Bachelor s degree in Engineering/Science related field or equivalentyears of experience. A minimum of 5 years of experience in the pharmaceutical industry with 3years of Validation experience. In depth knowledge of current validation principles, standardconcepts, practices, procedures and requirements in GMP regulated environments Experience in Statistical Analysis a plus.