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Principal Tech Engineer – Site Serialisation Systems

GSK plc
NewPosted yesterday

LOCATION

Bengaluru Luxor North · Remote

EXPERIENCE

7+ Years

TYPE

FullTime

SKILLS REQUIRED

Pharmaceutical SerialisationTechnical LeadershipRoot Cause AnalysisRegulatory Compliance

Job description

Overview

Provide hands-on technical leadership for GSK's 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, aligned with approved architecture, product strategy, engineering standards and GxP requirements.

What you'll do

  • 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.
  • 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.
  • 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, and hold them to GSK engineering, architecture, security and GxP standards.

What you'll need

  • Minimum 7+ years of hands-on technical engineering experience in complex enterprise or operational technology environments, including experience with GxP-regulated manufacturing systems.
  • 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 and knowledge.
  • Experience supporting audits, inspections or formal technical assurance activities.

Nice to have

  • Demonstrable hands-on pharmaceutical serialisation / Track & Trace engineering experience covering production troubleshooting.
  • Strong analytical and structured problem-solving skills.
  • Clear technical writing and disciplined maintenance of specifications, designs, test evidence and configuration records.
  • Practical use of AI-assisted development, agent-based workflows and prompt templates for engineering, testing, documentation and support, applied within Responsible AI, data privacy, cyber security and GxP controls.
  • Technical leadership and ability to challenge designs constructively.
  • Coaching and knowledge-transfer capability.
  • Confidence communicating technical risk and recommendations to governance and senior stakeholders.

Details

  • Location: Bengaluru Luxor North Tower.
  • Works across the site serialisation estate rather than being tied to a single site.

Read the full description and apply on the company’s own careers page.

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Principal Tech Engineer – Site Serialisation Systems