Apply on Employer Site

Katalyst CRO · 2 months ago

IT Validation Consultant

Raleigh, NC

Contract

Onsite

Senior Level

5+ years exp

Katalyst Healthcares & Life Sciences is seeking an IT Validation Consultant to develop and execute IT validation activities and documentation. The role involves ensuring compliance with regulations, participating in investigations of validation deviations, and supporting IT system lifecycle activities.

AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance

Comp. & Benefits

H1B Sponsor Likely

Responsibilities

Develop and execute IT validation activities and documentation, including protocols, test plans, and change controls

Author validation plans, verification reports, and decommissioning documentation

Ensure compliance with internal SOPs and external regulations (21 CFR Part 11, GxP, etc)

Participate in investigations of validation deviations and implement corrective actions

Support IT system lifecycle activities, including maintenance, incident management, and risk assessments

Conduct system reviews to ensure compliance and security controls are in place

Qualification

Computerised system validationGxP documentationValidation documentation creationPharmaceutical manufacturing processesBachelor's degree

Required

Minimum 5 years of experience in computerised system validation within pharmaceutical or life sciences projects

Strong knowledge of GxP documentation requirements and regulatory audits

Ability to create validation documentation independently

Preferred

Bachelor's degree in engineering, Computer Science, or related technical field

Familiarity with pharmaceutical manufacturing processes (Fill/Finish)

Company

Katalyst CRO

Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.

South Plainfield, New Jersey, USA

51-200 employees

http://katalysthls.com

H1B Sponsorship

Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (37)

2024 (14)

2023 (24)

2022 (52)

2021 (54)

2020 (39)

Funding

Current Stage

Growth Stage

Leadership Team

John Patil

Recruiter, Pharma/CRO Staffing Division

Recent News

Katalyst HealthCares & Life Sciences on LinkedIn: Candidate Portal

2024-04-07

Company data provided by crunchbase