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Sr. MES Engineer

Date: Mar 22, 2021

Location: Philadelphia, PA, US

Company: Spark Therapeutics

Join the Spark Team

 

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable – until now.

 

We don’t follow footsteps. We create the path.

 

 

The Sr MES Engineer will provide leadership to contractors and third-party partners to deliver new capabilities and continuous improvement of the Syncade MES (Manufacturing Execution System). This role will be a hands-on leader, actively involved in project delivery. The individual will set the overall direction for the technical design, utilization, integration and expansion of the MES Systems in Spark. The role will collaborate and partner with the key business stakeholders, including Technology, Operations and IT.  The role will act as an internal advisor and visionary on emerging technologies and their application to our emerging field of Gene Therapy and be an integral part of developing the overall Digital Strategy for Spark.  Systems in the scope of this role include:

 

 

Development of the MES Strategy and Project Execution

Deployment of integrated Weigh & Dispense (W&D), Electronic Batch Records (eBRs), Electronic Equipment Logbooks (eEL), and other MES system functionality.

Process Control integration Strategy & Project Execution

Vendor Packaged Equipment Control Integration Strategy & Execution

Plant Floor instrumentation & Standalone Systems Integration Strategy & Execution

Plant Floor System Architecture and Data Flow Strategy to support Data Science initiatives

Integrate with Quality on Data Integrity Initiatives at the Plant Floor Level

Collaborate with other functions for Vendor Management for all MES/Automation suppliers and integrators.

Finite Scheduling for Manufacturing, Maintenance, Sampling and Projects (BioG)

Familiarity with LIMS and other quality solutions.

 

 

Responsibilities

 

  • Provide leadership, vision and direction on the Plant Floor/OT MES Systems to ensure it will contribute to the company achieving its goals. Drive business case definition / requirements for key projects and digital transformation. Evaluate conceptual aspects of technical designs to ensure sound decisions and investments are made in accordance with business strategy and internal policy/governance and assess new innovative technologies.

 

  • Ensure plans are created and updated in a timely manner, communicated to relevant stakeholders, assess risks, and manage deliverables. Meet scheduled milestones to ensure project/program objectives are met in a timely manner. Use agile development principles, in accordance with Corporate IT standards, where applicable.

 

  • Manage team of contractors and third party vendors to deliver on all projects and activities. Effectively delegate responsibilities to achieve goals, while ensuring optimal oversight and supervision to ensure goals are achieved.

 

  • Build strong relationships with the vendor ecosystem in order to understand trends and to build additional capacity to deliver business value. Manage development of new contracts and adherence to existing contracts.

 

  • Collaborate with Corporate IT to ensure all Technology and enterprise information and technology assets leveraged by Technology are ideated, evaluated and selected, approved, constructed, delivered and supported in accordance to Spark IT principles, policies and standards for security and privacy, technology architecture, technology delivery lifecycle (e.g. SLDC, Agile), technology operations and Spark IT Operating, Delivery and Support Models. 

 

  • Identify opportunities to improve existing processes, equipment, systems, and infrastructure by both leveraging and setting industry best practices.

 

 

 

Requirements

 

  • BS/MS/PhD in Life Science/Engineering or related field required. 
  • Minimum 10 years of experience in the Biotechnology or Pharmaceutical industry working with MES applications / functionality.
  • >10 years of direct supervisory experience of technical professionals and managerial level staff with demonstrated effectiveness in providing guidance, mentorship and support to staff. 
  • Experience in biopharmaceutical based GCP/GLP/GMP environments including direct experience in developing/deploying/supporting MES and other Plant Floor/OT systems/tools in a cGMP Environment with a deep understanding of ISA 95 and ISA 88 industry standards
  • Proven track record organizing and delivering applications from concept to go-live in a real plant manufacturing environment.
  • Demonstrated technical project management experience to develop project goals, budgets, deliverables and timelines
  • Knowledge of GXP compliance and experience with Data Integrity elements of the various systems.

 

 

Competencies

 

  • Pharma/Industry 4.0 and enterprise knowledge, including an understanding of the organization’s business strategies and processes, to sustain an application solution roadmap that supports the business’ goals. Remain current on industry trends in process and systems.
  • Experienced leader in business process/digital transformation
  • Process Automation, IoT, Cybersecurity, shop floor devices, control systems, data historians, process analytical software, predictive analytics, supply chain modeling, finite production scheduling, and integration to higher level systems in a Industry/Pharma 4.0 environment.
  • Integration of Manufacturing Execution Systems (MES) with LIMS and Enterprise Resource Planning (ERP) and associated systems to higher level systems in an Industry/Pharma 4.0 environment.
  • Regulatory Inspections, Good Manufacturing Practice (GMP), Change Control, Validation
  • Demonstrated ability to prioritize and coordinate activities within and across work groups; able to anticipate priority differences and issues and resolves these before problems occur, exceeds desired results.
  • Participates in the budget development process; effectively controls the controllable expenses (Contract Spend, Supplies, T&E) within their influence.
  • Develops stretch goals and uses effective motivation techniques to achieve them.  Strong team diagnostic skill and strategy for team growth.  Shapes GXP IT goals and policies.  Able to effectively lead cross functional teams.
  • Ability to motivate staff, foster a culture of continuous improvement and agile execution
     
  • Ability to prepare contingency plans and logically work through complex issues in a pressure filled atmosphere

 


Nearest Major Market: Philadelphia