Sr. CSV/CSA/Validation Engineer

Katalyst-Healthcares-; Raritan (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

Creative Solutions Services, LLC seeks a seasoned Validation lead with strong GxP and CSV expertise. The role focuses on independent support for business separation activities of large global GxP systems, including acquisition/divestiture projects.

You will guide junior and senior staff, collaborate with remote teams, and manage end-to-end validation across infrastructure and cloud-based applications. Experience in regulated environments, risk-based validation, and comprehensive validation

Qualifications

• Experience in FDA- or Global-regulated environments with GxP standards and risk-based validation.
• Ability to define and implement risk-based validation activities.
• Experience in writing and executing documentation for validation deliverables (requirements, validation plans, test protocols, test reports, SOPs).
• Experience in QA methodologies, designing and approving test plans, test scripts and procedures.

Responsibilities

• Lead/advise junior and senior resources in CSV and validation projects.
• Support Business Separation activities for large global and regional GxP computerized systems with minimal supervision.
• Manage end-to-end validation processes from inventory, assessments, remediations to final dispositions.
• Work with remote teams and support multiple changes/projects simultaneously.

Skills

Team player

Lead a team

Remote collaboration

Validation guidance

Job description

Roles & Responsibilities:

• Need someone strong with GXP applications, saas/paas, infrastructure, quality, cloud concepts, cloud applications, etc.
• In addition to validation and regulation experience, the resource should have the following experience:
• Must be able to Independently support Business Separation activities for Large global & regional GxP Computerized systems. With minimal supervison.
• Strong CSV Expertise, especially within Acquisition/Divestiture/Separation.
• Ability to manage end-end from Inventory, assessments, remediations to final dispositions;
• Infrastructure Qualifications & Business Systems Validations 7-10 years of relevant experience; has experience of leading/advising Junior and Senior resources.
• Specifically in the Pharmaceutical, biotechnology, or medical device industry.

Experience:

• Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation;
• Define and implement Risk based validation activities.
• 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, SOPs/WIs).
• 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.

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 management