Cognizant is a world leader in delivering digital transformation solutions to Life Sciences. Through our knowledge and expertise in Automation, MES & Digital, we deliver stable manufacturing systems that are optimized to improve operational efficiencies, whilst maintaining compliance.
Our specialist engineering teams have the aptitude to deliver and support Pharma 4.0 architectures and solutions covering all IT, OT and IoT applications, infrastructures and services
The Subject Matter Expert (SME) will provide technical leadership in MSAT and advanced process data analytics, with a primary focus on multivariate analysis and process understanding using Sartorius SIMCA. This is a client-facing, support-oriented role within a managed services model, responsible for responding to data/analytics issues, troubleshooting complex manufacturing data challenges, and delivering reliable outcomes aligned to agreed Service Level Agreements (SLAs). The SME will develop, deploy, and sustain data-driven monitoring and troubleshooting solutions across GxP-regulated life sciences manufacturing, leveraging AVEVA PI as a core data historian and integration platform. The SME will partner cross-functionally with client Manufacturing, Quality, Process Engineering, Automation, and Digital teams to improve process robustness, product quality, and operational performance.
Responsibilities:
- Serve as the site/enterprise expert for multivariate data analysis (MVDA), chemometrics, and advanced statistical monitoring, using Sartorius SIMCA as the primary platform.
- Operate as a primary point of contact for client stakeholders for SIMCA/PI analytics support, including intake, triage, prioritization, and clear status communication.
- Own technical troubleshooting across the analytics stack (data ingestion, contextualization, model execution, visualization), driving rapid restoration of service in line with SLAs.
- Lead structured problem solving and root-cause analysis (RCA) for recurring issues, documenting findings and implementing preventative actions.
- Design, build, validate, and maintain MVDA models (e.g., PCA, PLS) for process monitoring, deviation investigation, root-cause analysis, and continued process verification (CPV) support.
- Partner with MSAT to translate process knowledge into data requirements, analytical strategies, and fit-for-purpose models (e.g., batch-to-batch comparability, golden batch, fault detection).
- Lead or support GxP-compliant implementation of analytics solutions, including documentation, validation/qualification activities, and data integrity controls (ALCOA+).
- Develop and sustain AVEVA PI use-cases: data ingestion, tagging strategies, event frames, calculations, dashboards, and integration with analytics environments – including cloud
- Establish best practices for data acquisition, contextualization, and cleansing for batch and continuous processes; ensure traceability from raw signals to reports and decisions. GxP context always a key consideration.
- Support creation and maintain standard workflows, runbooks, and templates for SIMCA projects (data preparation, model lifecycle management, versioning, performance tracking, periodic review).
- Track and report service performance metrics (e.g., response/resolution times, SLA attainment, backlog health) and drive continual service improvement.
- Provide expert support during investigations, CAPAs, RCAs, change controls, and regulatory inspections, supplying defensible analyses and clear, compliant narratives.
- Train and mentor colleagues (MSAT, Manufacturing, Quality) on MVDA concepts, SIMCA usage, PI data interpretation, and statistical thinking.
- Contribute to PAT strategy by identifying opportunities for real-time/near-real-time monitoring, soft sensors, and enhanced control strategies.
- Collaborate with IT/OT and Automation teams to ensure secure, compliant data flows between systems and appropriate access controls.
- Help manage the vendor relationship/s; i.e. OEMs and partners.
- Support continuous improvement by identifying high-value analytics opportunities, quantifying benefits, and tracking performance post-deployment.
Requirements:
- Bachelor’s degree or higher in Chemical Engineering, Biochemical Engineering, Chemistry, Pharmaceutical Sciences, Statistics, Data Science, or a related discipline (or equivalent experience).
- Demonstrated experience in MSAT, process characterization, tech transfer, CPV, or manufacturing process support within the life sciences industry (biopharma, pharma, vaccines, medical devices, etc.).
- Proven experience in a support/operations role (e.g., managed services, application support, process monitoring support), including ticket-based work, prioritization, and delivery against SLAs.
- Advanced working knowledge of multivariate analysis/chemometrics and practical experience developing MVDA models for manufacturing data.
- Hands-on expertise with Sartorius SIMCA (model development, diagnostics, deployment, lifecycle management).
- Hands-on expertise with AVEVA PI (historian concepts, data extraction, contextualization, and use in manufacturing analytics).
- Strong understanding of GxP expectations and data integrity principles (e.g., ALCOA+), including experience working in validated environments.
- Familiarity with ISA-95 model and UNS knowledge beneficial.
- Strong coding skills and ability to work with data programmatically; proficiency in one or more of Python, R, and MATLAB (including data wrangling, visualization, and statistical/ML libraries). Prior experience supporting data ingress and egress to/from SIMCA considered preferable.
- Excellent client-facing communication and technical writing skills, with the ability to translate complex analyses into clear actions and updates for diverse stakeholders.
- Customer/service mindset with strong client-facing communication, expectation management, and stakeholder engagement.
- Scientific and statistical rigor; strong problem-solving, troubleshooting, and root-cause analysis capability.
- Ability to connect process science with data signals and translate insights into practical actions and business context.
- Ability to prioritize effectively, manage multiple requests, and deliver to timelines and SLAs in a dynamic environment.
- Comfort working cross-functionally in fast-paced manufacturing environments.
- Strong ownership mindset, attention to detail, and commitment to compliance and patient safety.
- Ability to coach others and influence without authority.
Working Conditions / Travel
Role may require periodic on-site presence in manufacturing and/or laboratory environments and participation in on-call investigation support as needed. Occasional travel to other sites or vendors may be required on occasion.
The Cognizant community:
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About us:
Cognizant is one of the world's leading professional services companies, transforming clients' business, operating, and technology models for the digital era. Our unique industry-based, consultative approach helps clients envision, build, and run more innovative and efficient businesses. Headquartered in the U.S., Cognizant (a member of the NASDAQ-100 and one of Forbes World’s Best Employers 2024) is consistently listed among the most admired companies in the world. Learn how Cognizant helps clients lead with digital at www.cognizant.com