Sr. Data Engineer/Scientist

Key Skills

HTML, Java Programming, Design, Management, Risk Analytics, Python Programming, SQL, SQL Server, Data science techniques, Data Analytics, R Programming, Statistics, JMP, SAS, Data Engineering

Job Description

g and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 1.7 billion packs of medicine and 767 vaccine doses in 2021.

We continue to modernize, so we can launch even more new products at speed whilst turbo-charging delivery across our entire portfolio through our relentless focus on quality, safety, and service. The way we work will change. For some, the shift in technology and products will be revolutionary. Our R&D pipeline demands a new kind of supply chain, and we need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of automation and robotics so we can work smarter together.

Are you looking for a opportunity to work closely with automation and digital Operations ? If so, this is role for you.

As a Sr. Data Engineer/Scientist, this position supports process & product quality understanding & monitoring through the utilization of relevant data and quantitative methods. The role brings together capabilities in multiple areas including statistics/data mining, information technology, and process engineering. The position works within manufacturing supply chain including a wide variety of data sources and stakeholders: Research and Development (R&D) stakeholders engaged in technology transfer and ongoing technical risk analysis, manufacturing production and technology groups engaged in monitoring and investigations, analytical labs and subject matter experts involved in product release and stability testing, and engineering groups responsible for process control, reliability and robustness.

The position supports data management, including data collection and data retrieval from source systems, and maintaining the integrity of process databases. The position collaborates with stakeholders to translate business and regulatory objectives into the definition of solutions to achieve them. These informatics solutions may encompass a variety of on-line and off-line components including the desired user experience (e.g., filtering by batch number, data time, etc.), data management, univariate statistical trending, correlation & regression, data visualization, multivariate quality control, and multivariate analyses (MVA). The position supports supply chain stakeholders in their data sourcing and analysis needs specific to investigations, root cause analysis, technology transfer and process comparability, stability trending, and technical risk assessment & process robustness.

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following

• Collaborates with stakeholders to translate business and regulatory objectives into the definition of informatics (data management and data analysis) solutions to achieve them
• Leads data management, including data collection and data retrieval from source systems, and maintaining the integrity of process databases
• Designs and leads the delivery of informatics solutions which may encompass a variety of on-line and off-line components including the desired user experience (e.g., filtering by batch number, data time, etc.), data management, univariate statistical trending, correlation & regression
• Supports supply chain stakeholders in their data sourcing and analysis needs specific to investigations, root cause analysis, technology transfer and process comparability, stability trending, and technical risk assessment & process robustness
• Leads data trending/continued process verification (CPV) programs and the informatics components of investigations
• Deploy solutions under change management using computer validation for GxP
• Solutions will be implemented using a variety of data management tools, e.g.: Databases, Stored Procedures, Computer Programming, SQL, python, XML, HTML and others.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• BS in Data Science, Computer Science, Applied Statistics or equivalent technical discipline
• 5+ years relevant technical experience
• 3+ year experience with Programming

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

Domain

• Experience in biologics manufacturing with an understanding of typical upstream and downstream process unit operations and the data collected from each including process parameters, quality attributes, step and overall yields, microbial tests, etc.
• Combination of engineering and quantitative education and experience

GMP

• Experience delivering solutions that comply with 21 CFR Part 11 (e.g., for Data Entry forms & workflows)
• Experience delivering solutions by employing a computer systems validation lifecycle methodology
• Awareness and knowledge of relevant FDA and ICH guidelines (e.g., continued process verification)
• Experience with change management, including defining, managing, and completing change controls
• Experience with following internal guidance and SOPs for change management, data analytics, and other relevant areas
• Experience with periodic and annual product reviews

IT Processes

• IT Project Management
• Software development lifecycle
• Management and support of GMP computer systems

Technical

• Visual Basic programming (or similar object-oriented programming experience)
• Oracle & SQL Server Databases / Structured Query Language (SQL)
• Python and/or R
• Cloud Platform
• Database schema design
• Experience querying information from LIMS (and other normalized databases in which analytical, sample-based results are stored)
• Experience querying process data from a data historian (Aspen Manufacturing Suite/IP21 preferred)

Data Analytics

• Experience with STATISTICA (or similar experience using SAS, JMP, Minitab, Discoverant, and/or SIMCA)
• Applied experience with statistical process control
• Knowledge of multivariate analysis and process capability

Why GSK?

At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we’re making the biggest changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands.

With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of disease together – all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive.