Digital Transformation

Job Title: Manager – Digital Manufacturing

Job Location: Bangalore

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:

Lead the design, implementation, validation, integration and scale-up of industrial digitalization solutions across regulated manufacturing operations. The role owns the delivery of IIoT, Data Acquisition Systems (DAS), manufacturing data integration and validated digital platforms, ensuring reliable data, compliant computerized systems and measurable operational value.

Role Accountabilities:

Industrial Digitalization & IIoT

Lead deployment and expansion of IIoT and connected-manufacturing solutions across plants and functions.

Translate manufacturing, engineering, Manufacturing, and EHSS pain points into scalable digital use cases.

Drive real-time operational visibility, exception monitoring and adoption of digital dashboards.

Support Pharma 4.0 and smart-manufacturing roadmaps through practical, value-led implementation

Data Acquisition Systems & OT-IT Integration

Manage DAS (Data Acquisition System) implementation and onboarding of process, utility and equipment data.

Design and govern integrations across PLC, SCADA, DCS, historians, MES/e-BMR, enterprise applications and analytics platforms.

Ensure secure, reliable and contextualized data flow between OT and IT systems.

Define standards for equipment connectivity, tags, interfaces, data quality, time synchronization and system handover.

Ensure model performance, scalability, and reliability

Computer System Validation (CSV) & Compliance

Plan and execute risk-based CSV activities for GxP-relevant computerized systems in line with approved quality procedures.

Prepare, review and maintain validation deliverables such as validation plans, user requirements specifications, functional/design specifications, risk assessments, traceability matrices, IQ/OQ/PQ or equivalent test evidence, validation reports and system release documentation.

Ensure data integrity, audit trail, access control, electronic record and electronic signature requirements are addressed where applicable.

Coordinate validation with Quality, business process owners, IT, Engineering, vendors and system integrators.

Manage validation deviations, defects, change controls, periodic reviews, backup/restore evidence, incident impact assessments and retirement/decommissioning documentation.

Ensure validated state is sustained through the system lifecycle and that documentation is inspection ready.

Analytics, Dashboards & Value Realization

Enable dashboards and reports for equipment performance, utilities, asset health, process monitoring and operational review.

Build the data foundation for predictive maintenance, energy optimization and advanced analytics use cases.

Define baseline, benefit hypothesis, adoption measures and value-realization indicators for each use case.

Monitor solution usage, data reliability and business outcomes after go-live.

Program, Vendor & Stakeholder Management

Lead projects from discovery and requirements through design, validation, deployment, handover, adoption and value tracking.

Manage project scope, schedule, budget, risks, dependencies, quality and vendor performance.

Partner with Manufacturing, Engineering, Quality, IT Infrastructure, Cybersecurity and Data teams.

Present concise progress, risk and value updates to functional and digital leadership.

Coach project teams and site digital SPOCs on delivery discipline, documentation and adoption.

Syngene Values

All employees will consistently demonstrate alignment with our core values

 Excellence

 Integrity

 Professionalism

Preferred Skills & Expertise

Technical Skills

Industrial Platforms – IIoT platforms (Aveva PI preferred), data historians, DAS, edge connectivity and manufacturing dashboards

OT Systems – PLC, SCADA, DCS, industrial networks and protocols; equipment and utility data integration

CSV & GxP – Risk-based validation, validation lifecycle documents, testing, traceability, deviations, change control and periodic review

Data Integrity – ALCOA+ principles, audit trails, access controls, electronic records/signatures and lifecycle documentation

Integration & Data – OT-IT interfaces, APIs/middleware concepts, SQL and data visualization fundamentals

Security & Operations – OT cybersecurity fundamentals, backup/restore, incident assessment, system support and controlled release

Experience & Qualifications

Bachelor's or Diploma degree in Instrumentation, Electronics, Electrical, Computer Science, Mechanical, Chemical Engineering or a related discipline.

5-9 years of relevant experience in manufacturing IT, industrial automation, CSV, IIoT, OT systems integration or digital transformation.

Experience in pharmaceutical, biotechnology, life sciences, chemical or other regulated process manufacturing is strongly preferred.

Demonstrated experience delivering cross-functional technology projects in a GxP environment.

Certification or formal training in CSV, GAMP 5, industrial automation, project management, Aveva PI/OSIsoft PI or data analytics is desirable.

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 accommodation for qualified individuals with disabilities.