TOLMAR Inc. Sr. Validation Engineer in Fort Collins, Colorado
Purpose and ScopeResponsible for the development, execution, review and coordination ofvalidation activities including, commissioning, qualification, andvalidation (CQV) of facility, utilities, manufacturing processequipment, and cleaning validation for product manufacturing facilities.Essential Duties and Responsibilities Responsible for the change management for validated processes and equipment. Develops validation strategies for complex validation projects. Prepare and maintain site and project Validation Plans. Maintain and manage re-qualification schedules. Plan and coordinate specific validation activities for projects. Provide validation input to Engineering and Maintenance in equipmentpurchase requirements. Generate protocols and perform execution in the following validation areas; Temperature mapping of warehouses and temperature controlled chambers. Aseptic manufacturing equipment IQ and OQ Non-sterile manufacturing equipment IQ and OQ Utility system IQ and OQ Laboratory equipment IQ and OQ Automated systems qualifications Sterilization process PQ (Autoclaves, Dry Heat Ovens, Process SIP, VPHP) Cleaning validation (CIP/COP) Aseptic media simulations Product Process Validation Interface with Engineering, Facilities, Regulatory, andManufacturing personnel as needed. Review and approve cycle development initiatives and activities. Perform other related duties as assigned.Knowledge, Skills and Abilities Good technical skills and the ability to understand technicaldocumentation such as equipment manuals or drawings. 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. Effective organization and project management skills. Effective troubleshooting and problem solving skills. Ability to maintain gowning requirements as needed to access controlledareas. Ability to manage multiple projects simultaneously. Ability to work effectively both independently and in conjunction with ateam. Develop and implement creative solutions to problems. A valid driver's license and acceptable motor vehicle record required. Ability to train junior associates in validation principles.Education and Experience Bachelor's degree in Engineering or Science related field. Five or more years' experience in the pharmaceutical industry, minimumfour years in validation required. Demonstrated experience in four or more validation areas. Working Conditions Working conditions are normal for an office environment. Work may require occasional weekend and/or evening work. Work inside manufacturing clean rooms where gowning is required.