Dec 10, 2019
Job Description This leader in the global process automation group at Biogen is responsible for all process automation systems and manufacturing execution systems used at Biogen to support Pharmaceutical Operations and Technology (PO&T). Duties include: * Responsible for managing a global group of engineers accountable for the development, implementation and operational support of the next generation manufacturing execution philosophy and associated computerized systems for all batch processing activities. * Develops and implements global standards for process automation and MES software configurations, design specifications, new control strategies and software test protocols in support of new products, processes and systems. * Develops and implements global standards for control system and network hardware design, implementation and qualification. Ensures a robust strategy so that the above can be leveraged across sites. Develops, implements, maintains and governs S95/S88 Standards, Libraries, Interfaces & Systems, including: * Master Process Data * Recipe Libraries - Enterprise Recipe Management, through Development and Manufacturing. * Process Control (Level 1-2) * Manufacturing Execution & Historian (Level 3-4) * Based on project demands, may need to manage large team of contract engineers through peak periods. * Develops and implements a comprehensive overall design for electronic batch records and automated batch record review by exception, suitable for implementation at multiple global sites. * Ensures compliance with all regulatory, environmental, health and safety guidelines. * Creates an environment where leadership and talent development are a top priority, resulting in a high performing organization. * Creates and sustains a culture of innovation quality, compliance, accountability, employee engagement, diversity and inclusion. * As this is a global role, international travel (up to 50%) is required. Extended travel during critical manufacturing operation start up phases is expected. Qualifications * 10+ years' work experience, with at least 5 years related industry experience in a pharma, biotech,drug development or equivalent environment. Experience should demonstrate track record of success and leadership positions of increasing responsibility. * Direct, relevant experience managing individuals and multi-disciplinary, global cross-functional teams. * Specific experience in process automation, MES, batch manufacturing industry standards (ISA S88 &S95) * Formal or on the job experience in project management and strategic planning. Experience in Process Excellence methodology is desirable, but not required. * Excellent communication skills and a demonstrated ability to influence at all levels. * Direct experience designing, building, deploying and supporting automation and execution systems (Delta V/SCADA, Syncade MES, PAT, OSI Pi Data historian, etc.) in a regulated large scale pharmaceutical manufacturing environment. * Experience in running site-based shop floor systems in a globally distributed footprint is highly desirable. * Proven experience in supporting highly automated/paperless new plant shakedowns, startups, commissioning & commercial support. * Proficiency in maintaining computer network infrastructure. * Experience programming in DeltaV DCS. Knowledge of pharmaceutical/biotech manufacturing operations, through hands-on, on the floor experience. * Experience building, managing, and developing high performing, innovative and transformational process automation /execution systems across a global organization (US and EU). * A proven track record of influencing the industry on execution systems via publications and presentations is strongly preferred. Education: Bachelor's Degree in a relevant Engineering discipline with a minimum of 10 years of related industry experience As this is a global role, international travel (up to 50%) is required. Extended travel during critical manufacturing operation start up phases is expected. Additional Information All your information will be kept confidential according to EEO guidelines.
Professional Diversity Network
Research Triangle Park, Durham, NC, USA