Aldevron Validation / Metrology Manager in Fargo, North Dakota

Position Summary:The Validation/Metrology Manager is responsible for supporting and coordinating the work of the Validation / Metrology group to ensure that equipment is qualified, maintained and calibrated properly on schedule, complying to appropriate guidelines / specifications and internal procedures. Provides leadership in strategy and administration of internal and external programs and processes related to validation activities and metrology for the Aldevron Fargo site. Develops calibration methods and techniques based on principles of measurement science, technical analysis of measurement problems, and accuracy and precision requirements. Develops validation protocols meeting industry standards for equipment, utilities and processes to ensure Aldevron's regulatory compliance in support of client end use. Additionally, creates and revises Standard Operating Procedures (SOPs).Essential Duties and Responsibilities:Create and review Standard Operating Procedures, equipment records and qualification records Work with support departments to obtain user requirements for equipment/utility, assist in the vendor review, instrument demonstrations/evaluations and final vendor selection processManage the purchase, installation and qualification activities for new and relocated equipment/utilitiesMonitor the equipment utilization at all sites to move equipment in and out of service to minimize costs and maximize availabilityWork collaboratively with Manufacturing to develop process validation protocolsImplement and manage the Master Equipment List Responsible for hands-on calibration, supervisory functions, maintenance, troubleshooting, conducting investigations and repair on a variety of equipment/utilities in such a manner to have minimal interruptions within the manufacturing scheduleManages the identification, purchase, scheduling and administration of appropriate service contracts and calibration vendors. Responsible for determining the need for, identifying, contracting, and managing the efforts of outside consultants and contractorsManage the development and implementation of a validation maintenance program which periodically reviews the status of validated systemsManage the development, implementation, and maintenance of equipment preventative maintenance/calibration program to ensure availability for useEvaluates instrumentation specifications and design applications to identify potential issues that could result in operational vulnerabilities affecting regulatory compliance, excessive costs, reliability, and reduced system availabilityManage the development and execution of validation protocols for all facility services, utilities, equipment (including laboratory equipment), and systems including computer systems involved in regulatory processes. Manage the development and execution of the equipment cleaning validation program. This includes the development of a cleaning validation master plan for each unique process or product.Support activities for the retirement/re-designation of GMP equipment/utilitiesRecommends, champions, and administers process and procedure improvementsCreate and revise preventive maintenance, operational and calibration procedures for equipment/utilities throughout the facilityProvides technical expertise and training based on industry best practices to department and supporting departments, as applicableContributes to the identification and procurement of appropriate test, service, and safety equipment, as well as spare parts and materials for proper maintenance, operation and cleaning for equipment/utilities throughout the facilityDefine and optimize the overall validation strategies, policies, and programs. Programs to include change control as developed by the QA department. Strategic planning to include benchmarking against industry trends as well as continuous improvement in the validation program against current compliance standards and regulationsGenerate performance metrics assoc