Senior Consultant–Computer System Validation-Life Sciences

Overview

Senior Consultant– Computer System Validation
- Life Sciences

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

• Create, review, and approve validation deliverables
• Define IT system development processes (build, test, deploy, monitor) following Agile ways of working and ensure 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

• 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
• Collaborative attitude
• 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

• Strong understanding of pharmaceutical compliance regulations and validation concepts
• Experience with Agile and Waterfall methodologies
• Familiarity with tools like Service Now, 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

For candidates based out of NY/NJ states, estimated annual compensation will be $130,000 to $177,000.

• Medical/Dental/Vision/Life Insurance
• 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
• Paid holidays plus Paid Time Off

Infosys is a global leader in next-generation digital services and consulting. We enable clients in more than 50 countries to navigate their digital transformation. With over four decades of experience in managing the systems and workings of global enterprises, we expertly steer our clients through their digital journey. We do it by enabling the enterprise with an AI-powered core that helps prioritize the execution of change.

We also empower the business with agile digital at scale to deliver unprecedented levels of performance and customer delight. Our always-on learning agenda drives their continuous improvement through building and transferring digital skills, expertise, and ideas from our innovation ecosystem.

Infosys provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability.