Computer System Validation - Senior Consultant - Life Sciences

Weltraw Consulting Group; New York (NY); On-site; USD 110,000 - 170,000; Full time

Job summary

Weltraw Consulting Group seeks Senior Consultants with IT CSV expertise in Life Sciences. You will create, review, and approve validation deliverables, guiding IT systems development in line with regulatory requirements. Strong Agile, JIRA/Confluence/ALM experience and ability to manage multiple projects are essential.

Location includes New York area; candidate must be eligible to work in the US without sponsorship. Prior experience with audits and security controls will be valued.

Qualifications

• 5+ years in Life Sciences consulting or industry.
• Strong knowledge of 21 CFR Part 11, GxP and GAMP 5.
• Experience creating, reviewing and approving validation deliverables.
• Knowledge of risk management processes.
• Ability to manage multiple projects in complex environments.

Responsibilities

• Create, review, and approve validation deliverables.
• Define IT system development processes (build, test, deploy, monitor) with Agile and compliance.
• Work with Agile/JIRA, Confluence, ALM.
• Author major project validation deliverables per SOPs.
• Review and approve system lifecycle deliverables.
• Guide project teams on validation, security, and PM deliverables.
• Advise on compliance and security controls at development stages.
• Contribute to audits, assessments, or inspections.
• Escalate critical compliance findings to client units.
• Prepare management reports on compliance operations and progress.

Skills

Senior consultant

Life Sciences experience

IT CSV

Agile

Education

5+ years Life Sciences consulting experience

Tools

JIRA

Confluence

ALM

ServiceNow

Veeva

HPALM

Job description

About The Role

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 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.

Key Responsibilities

• MES


• ERP


• Veeva Vault


• LIMS


• Quality