MSAT Digital and Data Specialist

GSKMarietta, PA
Onsite

About The Position

The Digital and Data Analyst will support the MSAT organization by leveraging digital tools and data analytics to optimize manufacturing processes, improve product quality, and ensure regulatory compliance within the vaccine manufacturing site. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Develop and Implement Data Analytics Solutions: Design and deploy data analytics models to monitor and enhance manufacturing processes, ensuring data-driven decision-making. Collaborate with Cross-Functional Teams: Work closely with departments such as Quality, Operations, and IT to identify data needs, integrate data sources, and develop comprehensive analytics solutions. Utilize Digital Tools: Implement and manage digital tools for automated data collection, real-time monitoring, and advanced analytics to streamline manufacturing operations. Ensure Data Integrity and Accuracy: Maintain high standards of data quality by validating data sources, performing regular audits, and ensuring accurate data entry and processing. Support Digital Transformation Initiatives: Lead and participate in projects aimed at digitalizing manufacturing processes, enhancing data accessibility, and improving overall efficiency. Provide Training and Support: Educate team members on the use of data analytics tools and techniques, fostering a data-driven culture within the organization. Support Root Cause Analysis: Analyze process deviations and quality issues using data analytics to identify root causes and recommend corrective and preventive actions. Maintain Industry Knowledge: Stay updated with the latest trends, technologies, and best practices in data analytics and digital transformation to continuously improve processes. Ensure Regulatory Compliance: Adhere to regulatory requirements and company policies in all data-related activities, ensuring compliance with industry standards. Prepare and Present Insights: Compile and present data-driven insights and reports to stakeholders, supporting strategic decision-making and continuous improvement initiatives.

Requirements

  • Bachelor’s degree in engineering, pharmaceutical sciences, chemistry or related technical discipline.
  • 3+ years’ experience in pharmaceutical or biopharma manufacturing focused on single use systems or disposables.
  • Experience in qualification, validation or technical transfer of single use systems.
  • Experience preparing and executing technical protocols, reports and GMP documentation.

Nice To Haves

  • Advanced degree in engineering, pharmaceutical sciences or related field.
  • Knowledge of regulatory guidance and industry standards for extractables, leachable and sterility.
  • Experience working cross-functionally with operations, quality and suppliers.
  • Proficiency in Data Analytics Software: Advanced skills in programming languages and tools such as Python, R, SQL, and data visualization tools like Power BI.
  • Experience with Digital Tools and Platforms: Familiarity with Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS), and other digital platforms used in manufacturing environments like SAP.
  • Strong Problem-Solving and Analytical Skills: Ability to analyze complex data sets, identify trends, and develop actionable insights to improve manufacturing processes.
  • Excellent Communication and Collaboration Abilities: Strong verbal and written communication skills to effectively convey data-driven insights to stakeholders and collaborate with cross-functional teams.
  • Knowledge of Regulatory Requirements: Understanding of regulatory standards and compliance requirements in the pharmaceutical and vaccine manufacturing industry.
  • Project Management Skills: Ability to manage multiple projects simultaneously, prioritize tasks, and meet deadlines.
  • Attention to Detail: High level of accuracy and attention to detail in data analysis and reporting.
  • Continuous Learning and Adaptability: Willingness to stay updated with the latest industry trends, technologies, and best practices in data analytics and digital transformation.
  • Critical Thinking: Ability to think critically and independently to solve problems and make data-driven decisions.
  • Technical Writing: Proficiency in documenting processes, creating standard operating procedures (SOPs), and preparing technical reports.

Responsibilities

  • Develop and Implement Data Analytics Solutions: Design and deploy data analytics models to monitor and enhance manufacturing processes, ensuring data-driven decision-making.
  • Collaborate with Cross-Functional Teams: Work closely with departments such as Quality, Operations, and IT to identify data needs, integrate data sources, and develop comprehensive analytics solutions.
  • Utilize Digital Tools: Implement and manage digital tools for automated data collection, real-time monitoring, and advanced analytics to streamline manufacturing operations.
  • Ensure Data Integrity and Accuracy: Maintain high standards of data quality by validating data sources, performing regular audits, and ensuring accurate data entry and processing.
  • Support Digital Transformation Initiatives: Lead and participate in projects aimed at digitalizing manufacturing processes, enhancing data accessibility, and improving overall efficiency.
  • Provide Training and Support: Educate team members on the use of data analytics tools and techniques, fostering a data-driven culture within the organization.
  • Support Root Cause Analysis: Analyze process deviations and quality issues using data analytics to identify root causes and recommend corrective and preventive actions.
  • Maintain Industry Knowledge: Stay updated with the latest trends, technologies, and best practices in data analytics and digital transformation to continuously improve processes.
  • Ensure Regulatory Compliance: Adhere to regulatory requirements and company policies in all data-related activities, ensuring compliance with industry standards.
  • Prepare and Present Insights: Compile and present data-driven insights and reports to stakeholders, supporting strategic decision-making and continuous improvement initiatives.

Benefits

  • GSK US Benefits Summary
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