Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Digital transformation is a cornerstone of the continued development and expansion of Thermo Fisher’s global network of drug substance manufacturing sites. Our aim is to integrate best-in-class real-time data collection, visualization, and analytics into standard manufacturing workflows in each facility.

This role will take on responsibility for building, validating, and maintaining GxP data acquisition, analytics, and visualization solutions for use cases across the Biologics (BIO) business unit (BU). You will liaise with process SMEs in Manufacturing Sciences and Technology (MSAT) to define specific product and user requirements, build SQL queries and parameter logic within Discoverant, and work with IT and CSV to validate changes per a formal Software Development Lifecycle (SDLC) business process to deliver software solutions for efficient execution of Continued Process Verification (CPV) and routine process monitoring activities. You will also be able to take initiative to investigate feasibility of new tools and platforms to further streamline and enhance data analytics use cases across the network.

As part of the global Biologics Strategy and PMO group you will have the opportunity to work with various departments at all the manufacturing and development sites in the network. As such, the successful candidate will be a highly motivated self-starter who is able to work independently, remotely, and outside normal business hours with internal and external customers across multiple time zones in the US, Europe, and Asia-Pacific regions.

Key Responsibilities:

• Drive the execution and adoption of the process data analytics (PA) technologies and capabilities for the Biologics (BIO) business unit (BU).

• Build and maintain Discoverant product hierarchies for global BIO programs according to standard best practices for manufacturing process modelling and nomenclature under a formal SDLC change control process.

• Partner with global and site MSAT to build and deliver user requirements and streamline the execution of Continued Process Verification (CPV), routine process monitoring, and external data sharing activities through usage of Discoverant.

• Develop and integrate data visualization solutions into existing MSAT workflows including manufacturing process and material genealogy use cases.

• Work collaboratively to engage site leadership and technical SMEs to advance programs related to global process analytics.

• Liaise with Global IT, Computerized Systems Validation (CSV), and Data Engineering and Process Analytics (DEPA) to adhere to Discoverant platform-level best practices and procedures and provide input for future system enhancements and upgrades.

• Investigate the applicability of advanced analytical tools such as real-time multivariate process modelling or process knowledge management for improving development and manufacturing.

• Support or lead projects related to Pharma 4.0, AI/ML, and other digital transformation initiatives for the BIO BU.

Minimum Requirements/Qualifications:

Key Skills / Experience:

• Experience building and configuring process analytics data management systems such as Skyland PIMS, BIOVIA Discoverant, or TIBCO Statistica.

• Experience with systems integration, building SQL queries against relational databases for applications commonly used in pharmaceutical manufacturing facilities such as laboratory information management systems (LIMS), enterprise resource planning (ERP) systems, manufacturing execution systems (MES), distributed control systems (DCS), process data historian systems (AVEVA PI).

• Experience working with statistical analytics platforms (JMP/Minitab/R), data visualization applications (Power BI, Tableau, Spotfire) or programming languages (Python, Visual Basic, HTML/CSS) is a plus.

• Strong working knowledge of Statistical Process Control (SPC), Continued Process Verification (CPV), and basic statistics tools and methodologies is a plus.

• Working knowledge of the overall Biologics development and manufacturing process.

• Experience working in a cGMP Software Development Lifecycle (SDLC) environment.

• Ability to work in a matrix management system and influence and negotiate collaboratively with others without direct authority.

• Strong project management skills with proven ability to independently manage multiple milestones flexibly in an environment where priorities may change at short notice.

• Experienced with writing quality-controlled computerized systems design documents, policy documents and SOPs.

• Experienced in participating and leading process improvement and PPI Kaizen projects including the application of Lean/Six Sigma methodologies.

• Ability to work independently with minimal daily supervision.

• Ability to work outside normal business hours on a semi-regular basis to connect with colleagues in U.S., Europe, and Asia-Pacific time zones.

Qualifications & Experience :

• Bachelor’s Degree in Computer Science, Chemical Engineering, or STEM related discipline

• 3+ years of Computerized Systems Engineering, Data Engineering, or Data Analytics experience in a biopharmaceutical GMP manufacturing environment.

Compensation and Benefits:

The salary range estimated for this position based in Massachusetts is $66,000.00–$99,000.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards