This leader manages a mission critical function, Manufacturing Engineering, within Site Engineering and Facilities with accountability for the installation, validation and optimization of all manufacturing process equipment including cGxP warehouse technology. This is a key role on the Site E&F Leadership Team and for that reason, will frequently represent the Site E&F function in key decisions made at the Site Operations LT level related to Site Manufacturing strategy and direction.  Frequent interaction with manufacturing, quality, and other leadership peers for coordination and decision making in assigned Manufacturing Factories.  The leader will have a very strong technical foundation in pharma and/or bio-pharma manufacturing technologies, operations, and CQV practices; Demonstrates the ability to effectively lead a team of engineers to optimize the reliability and performance of all assigned manufacturing systems.  

This leader understands industry-wide and regulatory expectations for Facility, Utility, Equipment, and Cleaning Validation, and works with other members of management to ensure validation practices are consistent with requirements and expectations. Utilizes industry experience to drive the assessment and improvement of site validation practices; ensures that site validation practices meet corporate requirements; collaborates with site Quality Assurance leadership to determine an agreed-upon path forward on matters of Validation philosophy, implementing those philosophies, and incorporates into the standard operations of the department; defends validation protocols and explains concepts and policies to Regulatory inspectors; oversees direct reports in development and management of studies to respond to Regulatory observations; oversees direct reports in development and management of Validation Project Plans, Annual Validation Assessments, and similar summary documents; oversees direct reports in the development execution, tracking, and review of validation testing protocols for completeness, cGMP and data acceptability;  

This leader manages the development and performance of direct reports, including yearly goals, quarterly conversations and end-of-year performance reviews, compensation increases, and promotions, as applicable. 

This leader is accountable for aligning strategies and tactics with all other engineering and site functions. Works closely with the Head of Site E&F to develop Site E&F strategy, budgets, and resource models.  This leader will work through nominated senior matrix leaders within the Manufacturing Engineering function (as well as other Site E&F functions) to influence a thriving culture of development, performance and compliance.  The function will plan and co-ordinate daily operations to support production and quality metrics in full compliance with Safety and cGxP standards. Optimizes workflows and manages workload according to site priorities. Leads and develops staff and manages the expense budget associated with these activities. Ensures that procedures and technical documentation is accurate and current. 

• BSc degree in engineering or technical field required 

• Advanced degree preferred 

• 10+ years experience in the biotechnology, pharmaceutical or other regulated health care industries in an international business environment; 8+ years total experience in the areas of GMP validation, manufacturing, engineering or facilities 

• Large Opex/Capex budget experience  

• In-depth knowledge of Manufacturing operations in a Biopharma environment required 

• Proven record in project experience with large sites  

• Practical knowledge and application of GMPs, GLPs, and EMEA and ISO regulations 

• Experience dealing with FDA (or similar) investigators, authoring responses to critical, major or minor observations and implementing corrective measures 

• Experience in coordinating / leading cross-site or cross-functional initiatives 

Why Biogen?

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. Together, we pioneer. Together, we thrive.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts