Head of Automation & Manufacturing Execution Systems (MES), RTP Pharma

Job Description

About This Role:

The Head of Automation & MES is a key member of the RTP Pharma site leadership team and manages a site-based group accountable to the safe development, implementation and operational compliance of the Biogen RTP Pharma execution philosophy and associated plant execution/operations systems for all batch activities (both process and analytical testing), as well as supporting infrastructures. Plant execution/operations systems include DCS, SCADA, ParCS, MES, PLC, BMS and data systems such as historian and analytics solutions. 

The RTP Pharma site is home to our Parenteral Fill, Oral Solid Dose and Oligonucleotide Synthesis Manufacturing operations. Our campus is comprised of 3 buildings including a central utilities area and administrative offices. Additionally, we are in the final stages of a new Gene Therapy facility.

What You'll Do:

• Responsible for the automation for computerized systems of process unit ops and their lifecycle (where applicable) in support of all systems and MES functionality.
• Accountable for the delivery of all aspects of plant execution/operations systems to support site commissioning, validation, and on-going safety, compliance and quality manufacturing.
• Set and drive strategic priorities for the holistic systems technology landscape for the site, including but not limited to oversight of new plants/ facilities, changes to plant execution/operations systems, automation engineering systems, develop and maintain validation lifecycle strategy etc. Responsible to implement, validate, maintain and govern S95/S88 Standards, Libraries, Interfaces & Systems.        
• Accountable for the ongoing support and maintenance of all aspects of the plant execution/operations systems. Single Point of Contact for all plant execution/operations systems to key functions such as Manufacturing, Quality, Engineering, Manufacturing Sciences, Facilities and Maintenance. Ensure Pharma Automation Engineering functions as an aligned network with other sites and global automation and MES function.
• This includes developing strategic partnerships with Biogen global organizations, across the industry and involvement/participation in industry forums to exchange knowledge and best practices.
• Accountable to develop and manage the Leads along with a high performing team to deliver on above responsibilities. Create and sustain a culture of innovation, quality, compliance, accountability, employee engagement, collaboration, diversity and inclusion. Lead the site organizations through uncertain times or through large-scale, transformational change.
• Responsible for inspection/audit readiness (internal and external) in relation to the Automation systems at Pharma. Also accountable for adherence to cybersecurity corporate requirements, all engineering aspects of data integrity, and provide leadership support for alarm management.

Who You Are:

You are an experienced Automation Engineering leader with both experience in and a passion for managing multi-functional Automation and MES teams in a GMP environment.

Qualifications

Required:

• Bachelor’s Degree (BA/BS) from a four-year college or university in Engineering, Computer Science or other related field (M.S. or PhD strongly preferred)
• Minimum of 12 years of related experience in the Biotechnology/Pharmaceutical industry in an operational role
• Minimum of 5 years of managing technical teams (Automation Engineering and Manufacturing IT) as well as collaborating with multidisciplinary cross-functional teams.
• Demonstrated track record of success and leadership positions of increasing responsibility. A mindset of accountability, inclusiveness, agility, innovation and collaboration
• Technical experience and competence with implementation of DCS and MES systems is required; experience with data systems (such as historians). PLC and BMS systems experience are desired but not required
• Familiarity with industry standards for execution/operations system such as S88, S95, GAMP, computer systems validation and others
• Formal and/or on the job experience in business practices including budget management, project management, and strategic planning

Additional Information

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 c