Priyansh Bhatnagar

As a Senior MES PAS-X Lead, I have played a pivotal role in multiple installation and upgrade projects, demonstrating expertise in implementing and enhancing PAS-X applications. My responsibilities include designing robust architectures and integrations between PAS-X, SAP, and Level 2 systems, ensuring seamless operations. Collaborating closely with business stakeholders, I have developed comprehensive requirement and design documents and meticulously planned projects to meet critical deadlines. I have successfully led offshore teams to execute PAS-X installations and upgrades, set up the application from scratch, validated systems, and configured peripherals such as printers, scanners, and scales. Additionally, I have managed upgrades of PAS-X applications at production sites, achieving minimal downtime and ensuring continuity of operations. We developed a Confluence page to document MES known issues, providing a centralized resource for efficient troubleshooting. After each upgrade or installation project, we conducted lessons learned sessions to identify areas for improvement, enhancing delivery quality and consistently reducing production downtime.

As an MES PAS-X Consultant, I contributed to the successful implementation and enhancement of PAS-X applications from an offshore location. My role involved installing and upgrading the application, collaborating closely with the DBA, Automation, and other teams to establish seamless integrations. I managed change management processes, ensuring smooth transitions and adherence to best practices. Additionally, I developed critical documentation, including Installation Qualification (IQ), Operational Qualification (OQ), and comprehensive requirement and design specifications. Beyond technical contributions, I mentored team members, sharing expertise to build and nurture a proficient MES development team.

As a System Owner and Administrator for critical applications such as MES PAS-X, TrackWise, and ExtraView, I ensured their optimal functionality and compliance with regulatory standards. My responsibilities included conducting periodic reviews, such as access and GxP reviews, to support FDA audits and inspections. I was actively involved in incident, problem, and deviation management, taking the lead on significant deviations by performing root cause analyses, including 5-Why and trend analysis. Additionally, I managed system maintenance activities, verifying functionality post-maintenance to guarantee seamless operations. To enhance reliability, I implemented automated monitoring solutions for the PAS-X application, ensuring system availability and minimizing downtime.

As a System Administrator, I managed diverse applications across Quality Management, Environment Health Safety and Sustainability (EHSS), and Manufacturing domains. My experience includes configuring several Commercial Off-The-Shelf (COTS) applications, such as TrackWise, ExtraView, and Enablon, to align with organizational needs. I developed critical workflows in TrackWise, including Change Control, Deviation, and CAPA, and designed Safety Incident Management workflows in ExtraView. Additionally, I created seamless integrations between upstream and downstream systems using tools like Informatica and MuleSoft, ensuring efficient data flow and system interoperability.

After completing a comprehensive three-month training program, I joined a pharmaceutical project where I gained expertise in various applications and ITIL processes. My responsibilities encompassed incident management, change control management, and problem record management across Quality, EHSS, and MES tracks. I contributed by creating detailed Knowledge Base (KB) articles for known issues, ensuring efficient troubleshooting. Committed to excellence, I consistently delivered high-quality work, resolving major issues within SLA timelines. Additionally, I conducted root cause analyses (RCA) for recurring issues, implementing solutions to enhance system reliability and prevent future occurrences.