Director, MES Implementation & Integration

New Yesterday

Overview The Director of MES (Implementation and Integration) will drive the end-to-end implementation of Manufacturing Execution Systems (MES) across our biopharmaceutical facilities. You will develop and implement integration architectures connecting MES with Ignition, DeltaV, and Rockwell platforms, ensuring seamless deployment across retrofitted and future facilities while modernizing workflows to meet regulatory and operational standards. Responsibilities Contribute to the strategic vision of MES and lead the implementation and integration of the MES system across all manufacturing sites, while developing strong business relationships with stakeholder groups to attain a solid understanding of their goals and objectives. Develop tailored frameworks for MES integration with Ignition plant hubs, DeltaV control systems, and Rockwell HMI platforms, addressing distinct technical paradigms rather than unified strategies. Establish master data architecture frameworks to enable system deployment, ensuring validation and regulatory compliance across FDA-regulated environments. Manage complex validation requirements and change control processes while transforming paper-based batch records into compliant digital workflows. Diagnose and resolve integration challenges, including connectivity issues between disparate automation platforms, while maintaining quality and timeline constraints. Redesign workflow processes to leverage integrated system capabilities, optimizing operational efficiency and regulatory readiness. Provide MES team members with mentorship and support to ensure that they have the skills and tools required to consistently support business needs and individual professional goals. Qualifications Comprehensive understanding of biopharmaceutical manufacturing processes, batch record requirements, validation standards, and change control procedures within FDA-regulated environments. Experience managing process digitization initiatives that maintain regulatory compliance while enabling operational efficiency improvements through integrated system capabilities. Deep expertise addressing integration challenges across different automation platforms and system architectures. Proven ability diagnosing complex technical problems and implementing solutions under timeline pressure while maintaining quality and compliance standards. Education and Experience In order to be considered for this position, you must hold a BS degree in a life sciences, computer science or engineering discipline or related field and Associate Director: 10+ years of pharmaceutical/biotechnology industry experience Director: 12+ years of pharmaceutical/biotechnology industry experience May consider equivalent combination of education and experience. Level is determined based on qualifications relevant to the role. Equal Opportunity and Benefits Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. Salary Salary Range (annually) $145,600.00 - $282,600.00 For roles in the U.S., salary ranges shown are in accordance with U.S. law and apply to U.S.-based positions. For roles based in Japan and/or Canada, salary ranges are shown in accordance with applicable local law and currency. If you are outside the U.S., Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process and will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose is to verify information such as identity, right to work, and educational qualifications prior to commencement of employment.
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Location:
Troy, NY, United States
Job Type:
FullTime
Category:
Management & Operations

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