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Process Engineer

Date: Dec 1, 2020

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 Process Engineer position will be responsible for the following key tasks:

  • Developing User Requirements for Project Gateway and other new facility construction projects and existing facility retrofit projects
  • Working with A/E firms on developing process designs and facility fits with close collaboration with the Spark MS&T Group utilizing process visualization tools and process modeling software
  • Develop the Process Descriptions for each product to be deployed in both new and existing facilities.
  • Facilitate/Participate and drive all Process Design efforts including Process Designs, Equipment Specifications and Selection, Purchase Order Reviews, Equipment construction, FAT’s, Field Installation, Start-up and Troubleshooting
  • Act as a Process SME for existing Spark Processes to assist Site Engineering and Maintenance Teams
  • Start the development of a series of Spark Engineering Standards, leveraging work down by Roche from an upstream/downstream processing perspective.

 

Responsibilities

 

Provide direction on the Facility and Process Requirements (Both Upstream and Downstream) for new and existing facilities.  Be the key point of contact between engineering design firms and internal Spark Manufacturing and MS&T resources.  Evaluate conceptual aspects of technical process designs to ensure sound decisions and investments are made in accordance with business strategy and internal policy/governance and assess new innovative technologies.  Develop relationships with Roche Engineering resources and leverage existing facility and process designs, requirements documentation, and equipment vendor relationships and other design documentation from Roche.

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 rapid design principles in accordance to Corporate Standards.

Will be providing technical direction to external A/E firm partners and coordinating/facilitating internal reviews w/broad Spark stakeholders and also provide direction to contractors  working on behalf of Spark on various projects.

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

Collaborate with numerous teams within the Spark Technology Development Organization (Manufacturing, Digital Systems, MS&T, Process Development, and Quality) to ensure all facility and process assets are ideated, evaluated and selected, approved, constructed, delivered and supported in accordance to Spark IT principles, policies and standards. 

 

Education and Abilities Requirements

 

  • BS/MS in Chemical or BioChemical Engineering or related field required. 
  • Minimum 1 year of experience in the Biotechnology or Pharmaceutical industry.
  • Experience in biopharmaceutical based GCP/GLP/GMP environments
  • Proven track record organizing and delivering engineering design documentation from concept through detailed design, implementation and start up.
  • Minimum 1 year of experience developing user requirements and process designs for singe use Biologics facilities, both upstream and downstream processing unit operations and facility black and clean utility packages,
  • Adept at managing A/E firm resources and translating user requirements into actual conceptual, basic and detailed designs.
  • Demonstrated ability working with MS&T and Development groups to assist in developing scalable process designs to transfer into Clinical and Commercial manufacturing.
  • 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 Process & Equipment Engineering goals and policies.  Able to effectively lead cross functional teams.
  • Ability to motivate staff, foster a culture of continuous improvement and agile execution
  • Ensure resolution to all organizational, technical and quality/compliance issues of process designs in GMP regulated facilities

       #LI-JM1


Nearest Major Market: Philadelphia