Principal Tech Engineer - Site Serialisation Systems

GSK India

Bengaluru

On-site

INR 3,500,000 - 6,000,000

Full time

4 days ago
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Job summary

GSK India is seeking a Principal Tech Engineer for Site Serialisation Systems to lead design, validation and integration across the serialisation estate. You will ensure outputs meet architecture, product strategy and GxP standards while remaining hands-on with complex troubleshooting and optimization.

You will coach engineers, drive automation, and coordinate with vendors and partners to deliver scalable, compliant solutions across multiple sites and projects.

Qualifications

  • 7+ years hands-on technical engineering experience in complex environments.
  • Experience in Agile/product engineering environments.
  • Experience coordinating internal engineers, site teams, vendors and partners.
  • Experience in GxP-regulated manufacturing environments.

Responsibilities

  • Implement technical solution designs and configurations in accordance with approved architecture and product strategy.
  • Own technical quality for the assigned scope, including specifications, design documentation, configuration records and technical validation evidence.
  • Perform troubleshooting and root-cause analysis, with timely escalation where manufacturing batches, product quality, patient supply or data integrity may be affected.
  • Design or configure interfaces, workflows, recipes, data models and environments, including site serialisation system integrations.
  • Lead technical design and implementation across multiple projects, releases or sites.
  • Lead diagnosis and resolution of complex incidents, integration failures and data-integrity issues, and act as the technical authority over partner output against standards.

Skills

Technical leadership
Root-cause analysis
Systems integration
Automation

Tools

Version control
Automated testing

Job description

Job Purpose

The Principal Tech Engineer - Site Serialisation Systems provides technical leadership for site serialisation systems within PIMMS (the Manufacturing Track & Trace product), across the broader product family, technology platform or programme. The role leads solution design, validation, implementation and troubleshooting and ensures technical outputs align with approved architecture, product strategy, engineering standards and GxP requirements.

The role is hands-on and embedded close to business problems. The job holder personally investigates complex failures, interrogates data, logs and interfaces, challenges vendor and partner designs and resolves integration problems, rather than primarily coordinating or escalating them. The role works across the site serialisation estate rather than being tied to a single site and retains technical judgement and engineering integrity where strategic partners deliver routine build, test, deployment and support.

The job holder applies AI-assisted methods to development, troubleshooting, testing, documentation, knowledge management, monitoring and automation, while retaining full human accountability for technical decisions and GxP, Responsible AI, cyber security and architecture compliance.

The role also develops engineering capability by coaching engineers and super users and converting lessons learned into reusable designs, standards, training and knowledge.

Key Responsibilities
  • Implement technical solution designs and configurations in accordance with approved architecture and product strategy.
  • Own technical quality for the assigned scope, including specifications, design documentation, configuration records and technical validation evidence.
  • Perform troubleshooting and root-cause analysis, with timely escalation where manufacturing batches, product quality, patient supply or data integrity may be affected.
  • Design or configure interfaces, workflows, recipes, data models and environments, including site serialisation system integrations, and write or review related specifications and test scripts. Hold configurations, interface mappings and scripts under version control, subject changes to peer review, and verify them through repeatable automated or scripted tests, retaining traceable test evidence under approved change and GxP validation controls.
  • Own the technical reliability of site serialisation systems, including monitoring, recoverability, obsolescence and technical debt, addressing root causes so that incidents do not recur rather than closing individual tickets
  • Actively extract and codify existing serialisation knowledge into runbooks, integration patterns, troubleshooting guides and technical documentation, building capability across the wider engineering teams rather than creating a single point of dependency.
  • Lead technical design and implementation across multiple projects, releases or sites.
  • Review and approve key technical specifications, design documents, configurations, test scripts and validation evidence.
  • Lead diagnosis and resolution of complex incidents, integration failures and data-integrity issues, and act as the technical authority over strategic partner output - accepting or rejecting designs, configurations and test evidence against GSK engineering, architecture and regulatory standards.
  • Assess technical risks and ensure mitigation addresses security, compliance, resilience, data integrity and supportability.
  • Maintain technical standards and reusable engineering assets for the assigned product family or platform.
  • Support formal technical assurance, GxP validation, audits and inspections for regulated site systems and ensure corrective actions are evidence based.
  • Identify repetitive serialisation engineering and support activities suitable for automation, reduce manual diagnosis, testing, deployment and support effort, and reuse automation across sites rather than resolving the same problem repeatedly.
  • Apply AI-assisted methods to development, troubleshooting, testing, documentation and automation within Responsible AI, data privacy, cyber security and GxP controls, validating all output before use and retaining human accountability for technical decisions.
  • Direct and coordinate external vendors, system integrators and managed service partners across design, build, release and stabilisation; set technical direction and acceptance criteria for their work, review and formally accept or reject their designs, configurations and test evidence, and hold them to GSK engineering, architecture, security and GxP standards.
Key Relationships / Customers
Business and Site Stakeholders
  • Manufacturing, Quality, Supply Chain and APS stakeholders
  • Site engineers, automation teams, local Tech teams, super users and key users
  • Business Process Owners and operational risk owners
Digital & Technology Stakeholders
  • Product Managers and Product Owners
  • Solution and Enterprise Architects
  • Engineering, DevOps, Data and Integration teams
  • Service Managers, Cyber Security and Infrastructure teams
  • Validation, Quality and technical assurance teams
Other
  • Technology vendors, including but not limited to SEA Vision and Systech
  • System integrators and specialist engineering partners
  • Managed service and support providers
Area of Specialisation
  • Technical solution implementation and configuration, with emphasis on GxP systems
  • Interfaces, workflows, recipes, data models and environment design
  • Technical specifications, design documentation and validation evidence
  • Testing, release, deployment and configuration management
  • Logs, metrics, monitoring and root-cause analysis
  • Security, data integrity, resilience and supportability
  • GxP-regulated manufacturing technology environments, preferably including site serialisation systems
  • Technical leadership across products, sites or programmes
  • Design assurance and complex technical decision making
Basic Qualifications
  • Minimum 7+ years of hands-on technical engineering experience in complex enterprise or operational technology environments, including experience with GxP-regulated manufacturing systems, preferably including demonstrable hands-on pharmaceutical serialisation / Track & Trace engineering experience covering production troubleshooting.
  • Experience working in Agile or product engineering environments, including translating operational problems into backlog items, iterating quickly, demonstrating working solutions and partnering with product teams through lifecycle ownership.
  • Experience in leading technical design and implementation for a product family, platform, programme or multiple sites.
  • Experience maintaining configurations, interface mappings and scripts under version control, conducting peer reviews, and developing and executing repeatable automated or scripted tests, with traceable evidence. Experience reviewing and approving specifications, design documents, configurations, test scripts and technical validation evidence.
  • Demonstrated leadership of complex troubleshooting and root-cause investigations across systems, interfaces, workflows, data and infrastructure.
  • Experience coordinating internal engineers, site teams, vendors and specialist partners through design, deployment and stabilisation.
  • Experience assessing technical risk and ensuring security, data integrity, resilience, compliance and supportability requirements are met.
  • Experience coaching engineers and translating lessons learned into reusable standards, patterns
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