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Sr. Automation Engineer

Date: Jun 11, 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.

 

 

Summary

The Sr Automation Engineer is responsible for providing strategic direction and thought leadership for business system owners in the Technical Development & Operations organization. This individual will provide Project Leadership oversight to deliver a scalable, responsive, adaptive Plant Floor/OT landscape to enable the overall Technology Strategy and overall Integrated GXP Systems Architecture. The role will collaborate and partner with the key business stakeholders, including Technology, Operations, Quality 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:

 

  • Project Leadership for significant Automation and Digital Systems projects
  • Develop Strategy and Tools for Paper Based Documentation Digitization
  • OSi Pi Historian Strategy
  • Process Control Strategy & Project Execution
  • Vendor Packaged Equipment Control Strategy & Execution
  • Plant Floor OT Infrastructure and Cybersecurity Protections
  • Plant Floor System Architecture and Data Flow Strategy to support Data Science initiatives
  • Plant Floor Robotics Strategy and Project Execution
  • IIoT Infrastructure and Sensor Strategy and Project Execution
  • Advanced Control/Soft Sensor Design and PAT Integration to the Plant Floor
  • 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)
  • Advanced Reliability & Energy Monitoring and Optimization Strategy and Project Execution
  • Drug Product Filling/Packaging and OEE/RCA Tool Strategy and Project Execution

 

Responsibilities

  • Provide leadership, vision and direction on the Plant Floor/OT Digital 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.
  • Have Project Leadership experience of delivering significant Automation & Digital Systems Capital Projects
  • 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. 

 

Requirements

  • BS/MS/PhD in Life Science/Engineering or related field required. 
  • Minimum 15 years of experience in the Biotechnology or Pharmaceutical industry.
  • >10 years of direct supervisory experience of technical professionals 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, DCS, BMS, EMS, Robotics, OT Cyber Tools and other Plant Floor/OT systems/tools in a cGMP Environment.
  • 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.
  • 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