LS/ Consultant CSV - Business Consulting

Infosys • Indianapolis, NY

2d

About The Position

Infosys Consulting is seeking candidates at the Senior Consultant level with experience in IT Computerized System Validation (CSV) in the Life Sciences domain. The role involves supporting compliant system development and release processes, creating and reviewing validation deliverables, and advising project teams on validation, security, and project management requirements. Candidates should be able to contribute to audits and assessments, escalate compliance risks, and report on compliance operations and progress. The role is listed for New York, New Jersey, and Indianapolis. Applicants must be authorized to work in the United States without employer-based visa sponsorship; Infosys cannot provide immigration sponsorship for this role.

Requirements

• At least 3 years of professional experience in the Life Sciences industry, working for a consulting services organization and/or in industry.
• Strong understanding of pharmaceutical compliance regulations and validation concepts, including 21 CFR Part 11, GxP, and GAMP 5.
• Experience creating, reviewing, and approving validation deliverables.
• Knowledge of risk management processes.
• Experience with Agile and Waterfall methodologies.
• Ability to manage multiple projects and adapt quickly to changing situations in complex environments.
• Excellent communication and collaboration skills.
• Authorization to work for any employer in the United States without employer-based visa sponsorship.

Nice To Haves

• An IT background to understand program complexities.
• Familiarity with tools such as ServiceNow, JIRA, Veeva, and HPALM.

Responsibilities

• Create, review, and approve validation deliverables.
• Define IT system development processes for building, testing, deploying, and monitoring systems, using Agile ways of working and ensuring compliance in each release or iteration.
• Author major project validation deliverables according to client standard operating procedures.
• Review and approve system lifecycle deliverables generated by project teams.
• Guide project teams on applicable validation, security, and project management deliverables.
• Advise project teams on implementing compliance and security controls at appropriate stages of system development.
• Contribute to internal and external audits, assessments, or inspections.
• Escalate critical compliance findings, risks, or issues to appropriate client units.
• Prepare management reports on compliance operations and progress.

Benefits

• Medical, dental, vision, and life insurance.
• Long-term and short-term disability coverage.
• Health and dependent care reimbursement accounts.
• Accident, critical illness, hospital indemnity, and legal insurance.
• 401(k) plan, with contributions dependent on salary level.
• Paid holidays and paid time off.
• Competitive pay.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed