Sr. Director, Site Head of Engineering & Facilities - RTP Pharma

Job Description

About This Role:

The Site Head of Engineering & Facilities (Sr. Director level) is responsible for managing all engineering & facilities at Biogen's RTP Pharma site supporting manufacturing, laboratory, office, and the rest of site infrastructure operations.  This role is accountable for directing a team of highly technical professionals managing & executing activities in Manufacturing Engineering (includes ownership of process CQV), Facilities Engineering (includes ownership of clean utility and HVAC CQV), Manufacturing Maintenance, Facilities & Utilities Operations & Maintenance, Instrumentation & Controls, Maintenance Reliability, work order management, equipment asset lifecycle from user requirement specifications, design, installation, CQV testing, maintenance, spare parts management, engineering document management, decommissioning at the site, general site services and GMP/non-GMP cleaning. This role is also accountable for managing and executing the small capital project portfolio and representing the site in large capital projects at the site. 

This role is expected to actively participate as a key member of the Site Leadership Team and the Biogen PO&T Global Engineering & Facilities Leadership Team.  

What You'll Do:

• Provide Supervision and direction to functional teams for planning, execution, and prioritization of activities to support the daily manufacturing processes and schedule.  Includes oversight of shutdown planning /execution and management / execution of the site’s small capital project portfolio.  Monitor the performance of department goals and manage a direct staff of 6-8 personnel.  Develop, communicate, and implement strategic goals in support of Manufacturing Operations, 24/7 Utility Operations and Facility Utilization.  Includes accountability for Business Continuity (Emergency Response, Emergency Recovery, and Business Impact Assessments along with Risk and Criticality Assessments) planning and execution for equipment and systems at the site.
• Maintain compliance overall, with Corporate and Site Policies, cGMP, EHS, GEP/GES, and other regulations applicable locally and to the jurisdictional guidance within the scope of the role for all supporting functions. Drive a compliance-focused mindset into the organization by holding individuals personally accountable for their own compliance/safety and the compliance of others impacted by their work. Drive continual development of compliance/safety practices within the organization. Present engineering, facilities, validation, maintenance, pest control, cleaning, automation programs and deliverables to regulatory agencies. Ensure adherence to Quality Management System Global Directives, Global Engineering Systems guidance and best practices; procedures and best practices across sites are aligned as appropriate.  Ensure 24/7 coverage of site utilities and alarm management.
• Support Technology Transfers and the related equipment design, installation, commissioning, qualification, and validation (cleaning and CSV) activities to support the manufacturing schedule.
• Forecast and manage operational and site small capital expense budgets. Identify and implement system improvements and capital upgrades. Partner with Site leadership to plan and approve capital projects.

Who You Are:
You are an experienced leader with a strategic mindset, capable of driving innovation and excellence within the realms of engineering and facilities management. You possess deep expertise in the pharmaceutical/biotechnology industry, particularly in GMP manufacturing. Your leadership style is collaborative yet decisive and you excel at cultivating high-performing teams. With a finger on the pulse of industry trends, you are adept at shaping programs and operations that align with business objectives and regulatory standards. You are a clear communicator with the ability to influence and engage stakeholders across all levels. Your commitment to safety, compliance, and continuous improvement is unwavering, and you are ready to make a substantial impact on our site's success.

Qualifications

Required:

• Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Electrical Engineering, or directly related discipline. Advanced degree preferred
• 15+ years of experience with in-depth understanding of the pharmaceutical/biotechnology industry with a focus on GMP manufacturing
• Close connectivity to trends and developments as they pertain to the business of pharma/biotech, standards, and guidelines
• Experience in developing and maintaining engineering, facilities, maintenance, site services programs for a major site
• Working knowledge on entire life cycle of pharmaceutical/biotechnology process equipment, utilities and facility in