CSV Lead

Danta Technologies; Raritan (NJ); Hybrid; USD 55,000 - 83,000; Full time

Job summary

Danta Technologies in Raritan, NJ is seeking a CSV Lead to oversee validation and integration of LIMS LabVantage with CSV in a regulated environment. Remote work is possible, but a hybrid arrangement is preferred.

The role requires hands-on experience with FDA/GxP and the ability to write validation deliverables, manage testing activities, and lead a team across multiple projects with stakeholders located remotely.

Qualifications

• Experience in LIMS validation and CSV in regulated environments.
• Strong communication and leadership capabilities.
• Ability to coordinate with remote teams and stakeholders.

Responsibilities

• Lead validation lifecycle activities for LIMS LabVantage and CSV integration.
• Review and develop validation deliverables and test artifacts.
• Mentor team members and coordinate cross-functional efforts.

Skills

Team leadership

Communication skills

Remote collaboration

Tools

LIMS LabVantage

CSV

Job description

CSV Lead

Location: Raritan, NJ (Remote is fine, Hybrid preferred)

Pay Rate: $50/hr

Must Have: LIMS - Lab Vantage & CSV

Key Responsibilities

• " Experience in the Pharmaceutical, biotechnology with LIMS Labvantage related System Development Lifecyle in Computer System Validation Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.
• " Knowledge of FDA guidance's and industry standards (i.e., GAMP)
• " Experience in writing and executing documentation for all aspects of the validation deliverables (etc. Requirements, Compliance/validation Plans, test protocols, Test Summary reports and Compliance/Validation Reports.
• " Experience in reviewing system test and user acceptance test scripts, Traceability matrix and Design Specs.
• " Experience in QA Methodologies, designing, reviewing and approving Test Plans, systems and UAT test scripts and Test procedures.
• " Ability to Review Automated Test script Strong verbal and written communication skills.
• " Ability to work as a team player, lead a team or accomplish tasks without supervision.
• " Ability to work with remote teams and support several changes/projects simultaneously.
• " Ability to provide Validation guidance, timely reviews, and escalations to TQ management.

Notes:- All qualified applicants will receive consideration for employment without regard to race, color, religion, religious creed, sex, national origin, ancestry, age, physical or mental disability, medical condition, genetic information, military and veteran status, marital status, pregnancy, gender, gender expression, gender identity, sexual orientation, or any other characteristic protected by local law, regulation, or ordinance.

Benefits: Danta offers a compensation package to all W2 employees that are competitive in the industry. It consists of competitive pay, the option to elect healthcare insurance (Dental, Medical, Vision), Major holidays and Paid sick leave as per state law.

The rate/ Salary range is dependent on numerous factors including Qualification, Experience and Location.