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Process Engineer

Date: Jun 8, 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.

 

 

We are seeking highly motivated candidates with a passion for mapping and analysis of complex data sets; the output of which will drive investigation closure, enhanced process monitoring, continuous improvement, and data driven decision cycles. The Process Engineer is a key member of the  Manufacturing Process Performance Analysis (MPA) Group responsible for establishing systematic management and analysis of manufacturing and process performance data. This position will report to the MPA Group Lead and have extensive cross functional interactions.  The successful candidate will work closely with the, Manufacturing Science and Technology (MS&T) Team and Data Science Function to build capabilities in support of progressing Spark’s pipeline through the process/product life cycle. 

 

Primary Duties include:

  • Building enabled, current state data flow process maps and designing future state data flows from the point of data capture to analysis. 
  • Identifying and implementing data management toolsets in collaboration and at the direction of the Data Science, IT and GxP Digital systems Functions 
  • Routinely, compiling, capturing, trending, and analyzing process generated data and subsequently using these findings to drive process consistency, develop improvements, or identify root cause; with a bias toward continuous improvement. 
  • Documenting the findings of these analyses in reports that support the progression of programs through the product lifecycle.
  • Effectively leading GxP and non-GxP investigations in the role of Lead Investigator. 

 

Responsibilities

Describe the essential daily job functions and include % of time spent on each.

% of Time

Job Function and Description

Analysis

(~55%)

  • Gather, trend, monitor, and analyze process generated data to understand process capability; summarize findings in memos, reports, and presentations.
  • Develop contextual understanding of upstream and/or downstream gene therapy platform manufacturing processes.
  • Coordinate & manage various ongoing data streams to efficiently meet routine monitoring needs while establishing Lean standards. Establish new data streams as new processes/products/systems are brought online.
  • Participate in manufacturing process continuous improvement initiatives using data-driven approaches to identify areas of need and develop solutions.
  • Execute data requests and analysis as required by tech transfer teams, regulatory agencies, CMO partners, etc.
  • Develop, understand, and manage risk-based tools and templates that can be used to quantify impact and criticality for parameters and attributes within unit operations
  • Collaborate with MSAT lab team and in-house statistician to design and analyze  DOE studies in support of process characterization, investigational activities, or process improvement recommendations in accordance with the overall life cycle plan for the product.

Business Processes

(~30%)

  • Develop elements of MPA business processes required for the MPA group to deliver on the group objectives
  • Collaborate with cross-functional teams and other departments (Manufacturing, Quality Assurance, Process Development, etc.) to support efficient transfer of data and establish more effective knowledge management practices.
  • Support Management in the development of MPA as a core competency of MS&T.
  • Development of data flow maps from source, to point of analysis and implementation.
  • Facilitate and streamline access to information/data through the creation of various informational tools and guides.
  • Deploy self-service data tools to enable stakeholders to access data in ways that meet their needs.

15%

Manage individual performance to achieve business goals and objectives, as well ongoing professional development.

  • Manage performance: know what is expected, what it takes to be successful, and self-monitor progress.   Be accountable to achieve results while demonstrating the Spark Values. Periodically review individual objectives to ensure alignment to corporate and functional objectives, making adjustments if priorities have shifted.
  • Commit to collaborate.   Be a strong team player and business partner cross functionally. Understand the development goals, strengths and motivators of your colleagues and partner to achieve mutual success and continuous improvement as well as professional development. 
  • Foster Spark’s Culture, Mission, Vision, and Values:  Lead by example.  Create an environment where team members thrive in our Culture by living our truths, always in compliance with applicable laws and regulations. Emphasize to employees that “how” they achieve performance objectives is just as important as “what” they accomplish.

 

 

Requirements

  • Degree in Biological Sciences, Chemical or Life Science Engineering, Data Science, Computer Science, Applied Statistics, or related field required.
  • BS degree with 3+ years of relevant technical experience, or MS degree 1+ years of relevant experience in biologics process development, GMP manufacturing, or MSAT role (s).
  • Solid working knowledge of FDA, EMA, and ICH guidelines as applied to late stage and commercial phase biologics
  • Application of Data Integrity requirements in both GxP and non-GxP environments.
  • Experience using Excel for data mining and analysis is required. Experience with OSI Pi a plus.
  • Experience performing continuous process monitoring. Working knowledge of basic statistics including control charts, process capability, and statistical process control is required.
  • Demonstrated proficiency with at least one statistical programming package (e.g. SAS, JMP, Minitab, R) required. Experience with data visualization tools (e.g.  Spotfire, Tableau) preferred.
  • Preferred: Experience in cell and gene therapy or viral vector production. Accelerated CMC development pathways a plus
  • Preferred: Experience and knowledge of regulatory filings
  • Preferred: Previous experience with multivariate experiment/DOE design and analysis
  • Preferred: Knowledge of data modeling/statistical modeling and understanding of machine learning techniques and algorithms 

 


Nearest Major Market: Philadelphia