Staff IT Security

About Illumina:

Illumina is a leading developer, manufacturer, and marketer of life science tools and integrated systems dedicated to making genomics useful for all. Illumina's integrated Indian global hub in Bengaluru, Illumina India Biotechnology Private Limited, is focused on technology activities that will help usher in the next wave of innovation in healthcare and medical research. If you're eager to work on challenging projects that uses cutting-edge technology to transform the future of healthcare, this is your chance to join a truly remarkable team.

Job Description

Responsibilities:

• Advise project teams and internal GIS customers on validation scope, risk, and validation approach.
• Maintain and manage the status of validated applications.
• Conduct audit readiness checks.
• Participate in project and system requirements gathering/authoring and coordinate activities with business users and analysts.
• Coordinate the Change Management process within the GIS organization.
• Review system changes and provide compliance assessments and audit-ready closure summaries.
• Investigate root causes of defects and failures; author and/or investigate non-conformances and CAPAs.
• Provide direction, support, and motivation to team members to achieve organizational goals.
• Track key performance indicators, analyze data, and report on team progress to senior management.
• Manage projects and operations, ensuring effective use of resources.
• Address and resolve conflicts within the team and across functional groups, fostering a positive and productive work environment.

Listed responsibilities are essential but not exhaustive. Responsibilities may evolve based on business needs.

Requirements:

• 8+ years of experience in the life sciences industry focusing on computer systems validation.
• Strong oral and written communication skills to influence and advise stakeholders on regulatory compliance processes.
• Strong organizational skills for managing multiple validation projects.
• Experience working with cross-functional teams and aligning on validation strategies.
• Experience with enterprise applications such as SAP, LMS, Salesforce, ETQ, etc.
• Proficiency with test management tools such as HP Quality Center, ValGenesis, and TFS.
• Ability to articulate risk-based validation strategies tailored to business needs.
• Excellent customer service and interpersonal skills.
• Familiarity with regulations and frameworks such as 21 CFR Part 820/11, ISO 13485, and GAMP.
• Understanding of software development lifecycle activities, testing, and validation.
• Experience managing workload using IT service management ticketing tools, preferably ServiceNow.
• Knowledge of common IT infrastructure and applications, such as virtualization, directory services, storage, and DBMS.

People Leadership:

• Communicate clearly and effectively to keep the team informed and engaged.
• Identify and resolve problems, implementing solutions to improve efficiency and productivity.
• Define team objectives, develop strategies, and implement action plans to achieve goals.
• Delegate tasks and responsibilities effectively, ensuring alignment with overall goals.
• Enforce company policies and procedures, ensuring employee compliance with regulations.

Experience / Education:

• Typically requires a minimum of 8 years of experience in the life sciences industry with a bachelor's degree, or 5 years with a master's degree.
• Minimum of 3 years of experience in people management.

All listed requirements are considered essential functions of this position. However, reasonable accommodations may be made in response to changing business needs.