Process Validation Manager
1개월전에
We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment.
We believe that diversity is the driving force behind innovation, creativity, and overall business success.
Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals’ lives better makes life better – join our team today The Process Validation Manager provides leadership and guidance to the team members responsible for creating excellence in manufacturing process technology.
This position is accountable for enhancing process understanding and applying scientific principles to build sterile injectable products manufacturing capability.
This role reports to the Site Head and is a core member of the Site Leadership Team, who collectively steer the site short- and long-term business strategy. Functions, Duties, Tasks: Functional Leadership Responsibilities * Manage a Technical Service Manufacturing Science (TSMS) team to ensure that the scientific backbone of the manufacturing process is well characterized, applied, monitored, and documented. * Establish and manage functional Key Performance Indicators (KPIs) including budget. * People management: Coach and mentor direct reports. Core responsibilities * Closely monitor critical process data to drive deeper technical understanding and ensuring that processes are robust and validatable. * Collaborate and coordinate cross functional team to develop and maintain robust, scalable, cost effective and safe manufacturing processes in terms of quality and compliance aspect. * Manage validation activities (Process Validation, Cleaning Validation, Periodic Quality Review) at site and maintain all products in validated state. * Drive Aseptic Process Simulation (APS) to ensure sterile operation. * Responsible for Performance Qualification (PQ) of new equipment. * Investigate and resolve complex manufacturing issues relating to yield, quality, or throughput, and support manufacturing investigations and development of CAPAs. * Manage product technology transfers, new products scale up, process optimization, process validation of new products and processes. * Ensure the process and product is well characterized and that the process description, measures, acceptable ranges, specification has been documented in a process flow document (PFD) with their rationale. * Actively support site Operational Excellence initiatives and compliance enhancement activities. Minimum Qualification (education, experience and/or training, required certifications): * Bachelor’s degree in science or engineering field. * Minimum 10 years' experience and understanding of sterile injectable production quality systems in a GMP environment. * Ability to travel, not to exceed 10%. * English communication skill : able to communicate through meeting and email with global function. Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
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