Head of Site Engineering

1 month ago

Triangle Township, United States Biogen Full time
Job DescriptionJob DescriptionJob Description

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.
Qualifications

Required Skills

  • Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Electrical Engineering, Facilities Management 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 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
  • OpEx/CapEx budgeting experience
  • 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


Additional Information

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

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.

 

  • Head of Site Supply Chain, RTP Pharma

    1 month ago

    Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionAbout This Role:The Head of Site Supply Chain is a key member of the RTP Pharma site leadership team and is accountable for all Materials Management functions, warehouse and site logistics operations, site planning and scheduling, and related drug substance and drug product manufacturing support including...

  • Head of Global Facilities Engineering

    1 month ago

    Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionAs the Head of Global Facilities Engineering at Biogen, you will be the leading figure in our Facilities Engineering Technical Authority function. This Director level role will report into the VP of Global Engineering and Facilities and will champion subject matter expertise across diverse facilities engineering...

  • Head of Capital Management

    1 month ago

    Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionAs a member of the Global Engineering & Facilities (GEF) leadership team, this individual will lead the Capital Management function. Reporting to the Head of Global Engineering & Facilities, this role will be responsible for creating and maintaining a strategic program for all relevant capital portfolio, capital...

  • Head of Capital Management

    3 weeks ago

    Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionAs a member of the Global Engineering & Facilities (GEF) leadership team, this individual will lead the Capital Management function. Reporting to the Head of Global Engineering & Facilities, this role will be responsible for creating and maintaining a strategic program for all relevant capital portfolio, capital...

  • Site Civil Engineer

    3 weeks ago

    Ocean Township, United States WJH Engineering Full time

    Company DescriptionWJH Engineering is a team of talented professionals dedicated to providing clients with unparalleled service and value. We encourage a healthy work-life balanceJob Title:            Civil EngineerFLSA Status:      Non Exempt/ExemptGeneral Purpose:The primary responsibility of the Civil Engineer is the design and of land...

  • Sr. Engineer III, Automation

    1 month ago

    Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionReporting to the Head of RTP Site Automation, the Sr. Engineer III is a Subject Matter Expert (SME) in Distributed Control Systems (DeltaV DCS), Building management Systems (Rockwell BMS), Automation for Manufacturing Execution Systems (Syncade MES), and Digital and Data Systems (Pi Historian). The Sr. Engineer...

  • Sr. Engineer III, Automation

    4 weeks ago

    Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionReporting to the Head of RTP Site Automation, the Sr. Engineer III is a Subject Matter Expert (SME) in Distributed Control Systems (DeltaV DCS), Building management Systems (Rockwell BMS), Automation for Manufacturing Execution Systems (Syncade MES), and Digital and Data Systems (Pi Historian). The Sr. Engineer...

  • Junior Industrial Engineer

    2 weeks ago

    Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionAbout This Role The Global Engineering and Facilities organization is looking to hire a Junior Industrial Engineer. This individual contributor within one on of our functions (Biologics & Advanced Therapies, Fill Finish or ASO/Small molecule) is responsible for subject matter expertise in operational process...

  • Sr. Reliability Engineer I

    1 month ago

    Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionThe Sr. Reliability Engineer I applies Reliability Engineering methodologies to optimize design requirements and performance of critical assets across the site. Originates and develops analysis methods for determining reliability of components, equipment and processes. Acquires data and analyzes the data. Prepares...

  • Reliability Program Manager

    1 month ago

    Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionThis individual contributor who will report to the Head of Facilities Engineering Technical Authority is accountable for the development and implementation of a comprehensive reliability program that ensures the reliability, availability, and maintainability of our facilities, equipment, and systems across...

  • Engineer III, Automation

    2 weeks ago

    Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob Description About This RoleThe Automation Engineer III provides 24/7 process controls/automation technical site support to the Biogen 900 Davis drive, NC manufacturing site. In addition, this role manages multiple small OPEX/CAPEX projects and continuous improvement initiatives that support the site from initial conception...

  • Engineer II, Manufacturing

    3 days ago

    Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionAbout This RoleThe Manufacturing Engineer II designs, specifies, installs, commissions and validates new process equipment, provides engineering technical support and troubleshooting for assigned process equipment and a GMP biological manufacturing area such as Cell Culture, Harvest or Purification.  The...

  • Engineer III, Manufacturing

    4 weeks ago

    Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionAbout This RoleThe Manufacturing Engineer III designs, specifies, installs, commissions and validates new process equipment, provides engineering technical support and troubleshooting for assigned process equipment and a GMP biological manufacturing area such as Cell Culture, Harvest or Purification.  The...

  • Senior Engineer I, Fill Finish Technical Authority

    4 weeks ago

    Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionThe Fill Finish Engineering Technical Authority function (as part of the Global Engineering and Facilities function) is looking to hire an individual contributor who is accountable for subject matter expertise in fill finish engineering and technical operations as related to all Parenteral products manufactured. ...

  • Sr Engineer I, Automation

    1 month ago

    Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionAbout This RoleThe Sr. Engineer I, Automation provides 24/7 process controls/automation technical site support to the Biogen 900 Davis drive, NC manufacturing site. In addition, this role manages multiple small OPEX/CAPEX projects and continuous improvement initiatives that support the site from initial conception...

  • Sr Engineer I, Automation

    4 weeks ago

    Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionAbout This RoleThe Sr. Engineer I, Automation provides 24/7 process controls/automation technical site support to the Biogen 900 Davis drive, NC manufacturing site. In addition, this role manages multiple small OPEX/CAPEX projects and continuous improvement initiatives that support the site from initial conception...

  • Sr. Engineer I, Manufacturing

    1 month ago

    Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionAbout This RoleThe Manufacturing Sr Engineer I designs, specifies, installs, commissions and validates new process equipment, provides engineering technical support and troubleshooting for assigned process equipment and a GMP biological manufacturing area such as Cell Culture, Harvest or Purification. The...

  • Associate III, Quality Engineering

    1 month ago

    Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionAbout the RoleThe Quality Engineering (QE) Associate III is responsible for the oversight of key functional, tactical, and operational aspects within Quality Assurance at the Biogen Research Triangle Park (RTP) facility. The QE Associate III will perform all duties in a manner consistent with site and corporate...

  • Principal Capital Project Manager

    1 month ago

    Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionThe Capital Project Management function is looking to hire a Principal Capital Project Manager to lead projects and/or project activities that are generally considered to be moderately complex, which are projects that involve relatively high risk and multiple stakeholders, and relatively simple regulatory...

  • Engineer III, Global Automation

    2 weeks ago

    Triangle Township, United States Biogen Full time

    Job DescriptionJob DescriptionJob DescriptionAbout This RoleThe Automation Technical Authority Team within the Global Engineering function is looking to hire an Automation Engineer. This engineer is accountable for assisting in Capital Project planning and execution. This role effectively contributes and adds value to all stages of the asset's lifespan,...