Job Title: Senior Application Support Engineer

Job Location: Remote

About Syngene: Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply.

At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit.

Mandatory expectation for all roles as per Syngene safety guidelines

• Overall adherence to safe practices and procedures of oneself and the teams aligned
• Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company’s integrity & quality standards
• Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
• Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
• Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self
• Compliance to Syngene’s quality standards at all times

Core purpose of the role:

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 Sr 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: This is a remote position that involves 24/7 technical support, and we are seeking candidates who are comfortable working in rotational shifts.

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:

• Expert 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.

Equal Opportunity Employer:

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.