Job Summary Role Summary:

The IT Subject Matter Expert (SME) for Lonza MODA will be responsible for the implementation, configuration, validation, and ongoing support of the MODA Environmental Monitoring (EM) system within a regulated pharmaceutical environment. The role ensures system reliability, compliance (GxP/21 CFR Part 11), data integrity, and seamless integration with lab and manufacturing systems.

Areas Of Responsibility

Implementation Project Support
- Lead/support end-to-end deployment of Lonza MODA:
- Configure workflows, sampling plans, alert/action limits, and test methods in MODA.
- Coordinate with Lonza vendor team , QA, QC Microbiology, and Manufacturing stakeholders.
- Support system integration with:
- Participate in installation, upgrades, patches , and system enhancements.
Computer System Validation (CSV)
- Ensure adherence to GxP, 21 CFR Part 11, Annex 11, and data integrity requirements .
- Support/execute validation activities:
- Review and maintain validation documentation.
- Support audit readiness and regulatory inspections (FDA, EMA, MHRA, etc.).
Routine Operations Support
- Provide application support for MODA system issues.
- Manage incident, problem, and change requests (ITIL framework preferred).
- Monitor system performance, availability, and data accuracy.
- Perform routine maintenance activities :
- Troubleshoot issues with instrument interfaces and data capture.
Data Integrity Compliance
- Ensure ALCOA+ principles are followed for all data generated/stored in MODA.
- Support audit trails review , electronic signatures, and security controls.
- Collaborate with QA to ensure compliance with SOPs and regulatory requirements.
Stakeholder Collaboration
- Act as bridge between IT and business users (QC Microbiology / QA) .
- Conduct user training and knowledge sharing sessions.
- Work closely with global IT teams and vendors for issue resolution and enhancements.
Continuous Improvement
- Identify and implement process improvements and automation opportunities .
- Support system upgrades and new feature rollouts.
- Maintain and update SOPs, work instructions, and technical documentation.

Travel Estimate

Frequent travelling for Project requirement and routine support.

Job Scope

Internal Interactions (within the organization)

Yes

External Interactions (outside the organization)

Yes

Job Requirements

Educational Qualification

BE, B. Tech IT or Computter, BCA, MCA, BSc. / MSc. IT

Specific Certification

Experience

5-7 years

Skill (Functional Behavioural):

Strong problem-solving and analytical abilitie
Effective communication with cross-functional teams
Stakeholder management and vendor coordination
Documentation and audit readiness mindset

Disclaimer : This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

Manager 2 IT-Lonza Moda

Job Description

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