Senior Consultant- Computer System Validation- Life Sciences

Infosys Consulting; Indianapolis (IN); On-site; USD 130,000 - 170,000; Full time

Benefits offered by this job

Disability benefits

Health reimbursement accounts

Insurance (various)

401(k) plan

Job summary

Infosys Consulting seeks a Senior Consultant in the Life Sciences domain to lead Computerized System Validation efforts for IT systems. You will drive validation deliverables, ensure regulatory compliance, and collaborate with cross-functional teams across validation, security, and project management disciplines.

The role emphasizes audit support, risk management, and continuous improvement within Agile and Waterfall delivery models, with location options including Indianapolis.

Qualifications

• 5+ years of professional experience in Life Sciences consulting.
• Knowledge of 21 CFR Part 11, GxP, and GAMP 5.
• Experience creating, reviewing and approving validation deliverables.
• Knowledge of risk management processes.
• Thorough knowledge of compliance and validation concepts.
• Proven ability to support multiple projects in complex environments.
• IT background preferred to understand program complexities.

Responsibilities

• Create, review, and approve validation deliverables.
• Define IT system development processes following Agile methods and ensure compliance in each release/Iteration.
• Work with Agile/JIRA, Confluence, ALM.
• Author major project validation deliverables as per SOPs.
• Review and approve system lifecycle deliverables.
• Guide project teams on validation, security, and project management deliverables.
• Advise on compliance and security controls at development stages.
• Contribute to audits, assessments, or inspections.
• Escalate critical compliance findings and risks to client units.
• Prepare management reports on compliance operations and progress.

Skills

Pharma compliance

Agile & Waterfall

Multi-project mgmt

Communication skills

Tools

ServiceNow

JIRA

Veeva

HPALM

Job description

Senior Consultant, Business Consulting – Computer System Validation- Life Sciences

We are looking for smart, self-driven, high-energy people with intellectual curiosity and passion for excellence; specifically, we are looking for candidates at Senior Consultants levels who are experienced in IT Computerized System Validation (CSV) within Life Sciences domain.

Responsibilities

• Create, review, and approve validation deliverables
• Define IT system development processes (build, test, deploy, monitor) following Agile ways of working and ensure followed compliance in each release /Iteration
• Working experience on Agile/JIRA, Confluence, ALM
• Author major project validation deliverables as per client’s standard operating procedures
• Review and approve system lifecycle deliverables generated by project team
• Guide project teams on applicable validation, security, and project management deliverables
• Advise project team on implementation of compliance and security control requirements at the appropriate stages of system development
• Contribute to internal and external audits, assessments, or inspections
• Escalate critical compliance findings, risks, or issues into appropriate client units
• Prepare management reports regarding compliance operations and progress

Basic Skills & Experience

• 5 plus years of professional experience in the Life Sciences industry working for a consulting services organization and/or industry.
• Good understanding of key pharmaceutical compliance regulations like 21 CFR Part 11, GxP and GAMP 5.
• Experience creating, reviewing and approving validation deliverables.
• Knowledge of risk management processes.
• Thorough knowledge in compliance and validation concepts.
• Proven ability in supporting multiple projects, responding quickly to changing situations in complex environments.
• Preferable IT background to understand complexities on the program.
• Location: New York, New Jersey, Indianapolis
• Candidates authorized to work for any employer in US without employer-based visa sponsorship are welcome to apply. Infosys is unable to provide immigration sponsorship for this role at this time

Required Skills & Experience

• Strong understanding of pharmaceutical compliance regulations and validation concept
• Experience with Agile and Waterfall methodologies.
• Familiarity with tools like ServiceNow, JIRA, Veeva, HPALM.
• Ability to manage multiple projects and adapt to complex environments.
• IT background preferred to understand program complexities
• Excellent communication and collaboration skills.

Along with competitive pay, as a full-time Infosys employee you are also eligible for the following benefits :-

• Long-term/Short-term Disability
• Health and Dependent Care Reimbursement Accounts
• Insurance (Accident, Critical Illness, Hospital Indemnity, Legal)
• 401(k) plan and contributions dependent on salary level