IT CSV Lead

Comtech LLC; Raritan (NJ); On-site; USD 90,000 - 110,000; Full time

Job summary

A woman-owned IT solutions firm is seeking an IT CSV Lead located in Raritan, NJ. The successful candidate will have 7+ years of experience, focusing on validation testing, compliance planning, and cloud applications. Responsibilities include system releases to production, authoring UAT scripts, and comprehensive documentation. A bachelor's degree in a relevant field is essential, along with strong communication skills. The position is expected to last for at least 3 months, with potential for extension.

Qualifications

• 7+ years of total experience required.
• Good knowledge in validation testing, agile, and SDLC process.
• Experience with remediation process and compliance planning.

Responsibilities

• Responsible for system releases to production following change controls.
• Document test protocols and prepare summary reports.
• Develop and execute UAT scripts in collaboration with the business.

Skills

Validation Testing

Agile

SDLC process

Remediation process

Compliance analysis

Risk assessment

Cloud based applications

HPQC

ALM

Good communication skills

Education

Bachelor's degree in relevant field

Job description

Comtech is a woman-owned small business founded in 1998 and headquartered in Reston, VA. We offer IT solutions across the disciplines of program/project management, applications development, infrastructure, Cyber security, and enterprise content/data management services. We have developed our methodologies and processes based on the IT Infrastructure Library (ITIL) v.3 Framework across enterprise infrastructure operations. These methodologies and processes are reinforced through our organization’s externally accredited certifications, which include ISO 9001:2008 Quality Management System (QMS), ISO/IEC 20000-1:2011 IT Service Management Systems (SMS, corporate ITIL certification), ISO 27001:2005 Information Security Management System (ISMS), and CMMI-DEV Level 3

Job Description

Job title: IT CSV Lead.

Location: Raritan, NJ

Duration: 3 months + to start and positively will get extended

Skills Required:

• Total experience – 7+ yrs.
• Good Knowledge in Validation Testing, Agile and SDLC process
• Thorough knowledge in remediation process, decommission plans, preparing compliance plan, perform compliance analysis, gap analysis, risk assessment.
• Responsible for system release to production following change controls, CAPA.
• Good knowledge in performing validation for cloud based/COTS applications
• Provide trainings on CSV and GxP procedures and policies to offshore team
• GxP knowledge - worked in pharma and have knowledge in testing phases and deliverables
• Good knowledge of HPQC, ALM would be an added advantage.
• Able to work independently
• He/she has to do the complete documentation in writing test protocols, preparing summary report and coordinate with business in authoring test scripts.
• Author UAT scripts, execute, work closely with business in understanding the requirements.
• Good communication skill is mandate.
• Dry Run all scripts in the Dev environment

Qualifications

Qualifications:

• Bachelors degree in relevant field.