Head of Site Engineering - Raleigh, United States - Biogen

Description

Head of Site Engineering & Facilities, RTP Pharma

Full-time

Region:

US

About This Role:

The Head of Site Engineering & Facilities is responsible for managing all engineering & facilities at the 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.

Functions that are managed by the Head of Site Engineering & Facilities include Manufacturing Engineering (includes process CQV), Manufacturing Maintenance, Facilities Engineering (includes clean utility and HVAC CQV), Facilities Maintenance / Utilities Operations, I&C, Site Services, and Maintenance Reliability.

What You'll Do:

Provides 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. Monitoring the performance of department goals and managing the direct staff of 6-8 personnel. Develops, communicates, and implements 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.

Maintains 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.

Drives 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.

Ensures 24x7 coverage of site utilities and alarm management.

Supports Technology Transfers and the related equipment design, installation, commissioning, qualification, and validation (cleaning and CSV) activities to support the manufacturing schedule.

Forecasts and manages 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.
Required Skills
Bachelor's degree in Chemical Engineering, Mechanical Engineering, Electrical Engineering, Facilities Management or directly related discipline. Advanced degree preferred
12+ 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 infrastructure systems and basic working knowledge of process controls
Experience dealing with contracting services for large scale campus commercial and manufacturing settings
Demonstrated management and track record in contractor and partner safety metrics and contract management
Experience coaching, developing, and managing a staff of professional employees as well as contractors
Experience in campus utility infrastructure from a design and maintenance perspective
Ability to interpret and localize applicable requirements and guidance from authorities and regulatory agencies
Proven ability to lead and influence cross-functionally
Excellent communication and influencing skills
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.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law.

Biogen is an E-Verify Employer in the United States.

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