Senior Application Support Engineer

Syngene, established in 1993, is a leading contract research and manufacturing services organization offering drug discovery, development, and manufacturing services to global clients. Syngene s clients are world leaders in their fields, ranging from leading global multinationals to small and medium-sized start-ups, non-profit institutions, academic institutes and government organizations. Our dedicated R&D centers for Bristol Myers Squibb, Baxter and Amgen are an industry leading model with cutting-edge infrastructure, operating systems, processes, and procedures that comply with regulatory requirements with 1000+ dedicated scientists.

We are currently hiring for our dedicated center BMS with whom we have had a long-standing association for 15 years and are growing stronger. We have multiple positions open as we are setting up our Global Application Support team in India for Emerson Syncade and DeltaV which are key platforms in supporting the Manufacturing Execution System for various BMS manufacturing sites worldwide.

Reporting to the Application Support Lead Engineer, the successful candidate will be responsible for providing technical support to end users, with focus on supporting two main applications: Emerson Syncade and DeltaV. These two platforms are pivotal in supporting the Manufacturing Execution System for various BMS manufacturing sites globally. The Application Support Engineer will identify and resolve technical issues including developing and maintaining relationships with key stakeholders.

As an Application Support Engineer, you will be providing front line support to the Cell Therapy division for 4 offshore locations: Bothell, WA + Leiden, NL + Devens, MA + Summit, NJ.

Note:

Key responsibilities include

• Collaborate with business stakeholders and implementation partners to configure, build, and perform implementations, enhancements and bug fixes using Syncade MES.


• Work with business process leads to design master data, recipes, and define best practices.


• Provide support for operationalizing the manufacturing and peripheral systems.


• Ensure uninterrupted 24/7 operation of manufacturing systems for CAR T manufacturing, including on-call support on weekends on a rotation basis.


• Support daily operation and future enhancements of Syncade MES and other Manufacturing systems as an IT system owner and technical expert.


• Support integration initiatives between site manufacturing systems and above-site, enterprise systems, e. g. , LIMS, ERP, RTMS, etc.


• Triage and provide technical support to our users requests, with focus on supporting Emerson Syncade and DeltaV.


• Work closely with our users to identify and resolve technical issues, ensuring that they are resolved in a timely and efficient manner.


• Work independently and with internal teams to identify and resolve complex technical issues.


• Document and record issues and escalations in ServiceNow to help build and maintain a knowledge base related to technical aspects of the platforms.


• Follow escalation processes and interface with different tier teams as needed.


• Write Ad hoc SQL Queries to pull MES Data for non-urgent requests.

Basic Qualifications

• 5 to 8 years of experience in pharma/biotech projects, focusing on Manufacturing and IT disciplines.


• Knowledge of shop floor activities, Good Manufacturing Practices (GMPs), and process automation.


• Prior experience in Manufacturing Execution System (MES) and support, preferably Syncade MES.


• Bachelor s degree in Chemical, Mechanical, Biomedical, Electrical or Computer Engineering, or MIS discipline.


• Experience with reporting systems like Informetric InfoBatch.


• Experience with labeling systems like Bartender.


• Experience integrating MES with other enterprise applications like ERP(Oracle/SAP), LIMS, RTMS, etc.


• Ability to author, review, and approve technical documentation, protocols, and reports, including IQ/IQ/PQ protocols, change controls, and SOPs.

Preferred Qualifications:

• Understanding of Electronic Batch Records (EBR) and Review by Exception (RBE). Recipe Authoring is a plus.


• Experience with Microsoft SQL Server, reporting services, database design, and data architecture. Query creation in multiple database environments.


• Experience with Test Strategy, Test Management, and Defect Tracking Tools like HP ALM.


• BA/BS degree in Computer Science, Information Technology, Chemical Engineer or a related field. Associates or Technical degree will be considered.

Key skills desired

• Ability to navigate ambiguity and solve problems in a fast-paced environment.


• Strong technology acumen and understanding of the intersection of business & IT related challenges.


• Ability to make complexities more easily understood through speech and written narrative, and possess excellent professional written and verbal communication as well as interpersonal skills.


• Strong developer of effective partnerships and relationships with all levels and geographies.


• Commitment and passion for achieving desired outcomes such as customer satisfaction (i. e. , value, quality, speed).


• Be well organized, able to manage multiple tasks, and prioritize effectively.


• Possess patience and maturity and remain calm under pressure.


• Display a sense of urgency in completion of key responsibilities.


• Possess attention to detail.