LS/ Principal CSV- Business Consulting

Infosys • Bridgewater, NY

6d

About The Position

Principal 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 Principal Consultants levels who are experienced in IT Computerized System Validation (CSV) within Life Sciences domain. Infosys Consulting is the global management and technology consulting practice of Infosys, a global leader in technology services and consulting. We combine the power of time-tested methodologies, people-driven innovation and disruptive technology to enable leaders of the world’s top brands pursue a path of smart transformation. Together with our clients, internal and external partners, we co-create and execute pragmatic strategies and solutions that transform organizations and define the future of business. Our dynamically growing consultancy offers our consultants: Ability to design and implement end-to-end solutions at scale A flat organization structure with direct access to our senior-most leaders An entrepreneurial environment full of bright, highly motivated consultants Opportunities for motivated consultants to impact local communities The ability to design your career and drive your professional learning and development A truly global culture EEO 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.

Requirements

• 7 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.
• Candidates authorized to work for any employer in US without employer-based visa sponsorship are welcome to apply.
• Strong understanding of pharmaceutical compliance regulations and validation concepts.
• 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.
• Working experience on Agile/JIRA, Confluence, ALM

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
• 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

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: No Education Listed
• Number of Employees: 5,001-10,000 employees