LS/ Senior Consultant CSV - Business Consulting

Infosys Ltd

Bridgewater, NJ

JOB DETAILS
SKILLS
Agile Programming Methodologies, Artificial Intelligence (AI), Atlassian JIRA, Biology, Biotech and Pharmaceutical, Channel Strategies, Code of Federal Regulations, Communication Skills, Computer Systems, Consulting, External Audit, Global Branding, GxP, Healthcare Reimbursement, Information Technology & Information Systems, Internal Audit, Life Insurance, Maintain Compliance, Market Share, Medical Conditions, Multitasking, Project/Program Management, Regulatory Compliance, Reporting Skills, Risk Management, Security Compliance, ServiceNow, Standard Operating Procedures (SOP), System Lifecycle, System Validation, Team Player, Testing, Vision Plan, Waterfall Model of Software Development, Writing Skills
LOCATION
Bridgewater, NJ
POSTED
30+ days ago

2243992No5439232510.00.004/02/2026LS/ Senior Consultant CSV - Business ConsultingSenior 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.
  • 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

Required Skills & Experience

  • 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.

146534BRNew Jersey, New YorkUSAInfosys Limited Senior Associate - Business ConsultingITL USA Bridgewater, NJ, New York, NYLife SciencesProcess|Consulting processes|Technology Consulting process Senior Consultant-Computer System Validation-Life Sciences116875148125

Benefits

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

About Us

Infosys Consulting is a next-generation consulting partner that bridges strategy and execution. With an AI-first mindset, deep industry knowledge, and the combined strengths of business and technology consulting, it helps enterprises turn bold vision into tangible outcomes, faster, smarter, and at scale.

Infosys Consulting is helping some of the world's most recognizable brands transform and innovate. Our consultants are industry experts that lead complex change agendas driven by disruptive technology. With offices in 20 countries and backed by the power of the global Infosys brand, our teams help the C-suite navigate today's digital landscape to win market share and create shareholder value for lasting competitive advantage.

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.

About the Company

I

Infosys Ltd

Infosys is a global leader in next-generation digital services and consulting. We enable clients in 45 countries to navigate their digital transformation.

With over three 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.

COMPANY SIZE
10,000 employees or more
INDUSTRY
Computer/IT Services
WEBSITE
https://www.infosys.com/careers