CSV Analyst

Raas Infotek; Lansdale (Montgomery County); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Raas Infotek LTD is seeking a senior CSV specialist to lead compliance across capital and strategic projects. You will develop and approve validation deliverables in line with CFR 21 Part 11 and GAMP 5, while guiding project teams on SDLC and CSA approaches.

The role requires minimum 5 years of CSV experience in regulated life sciences environments, with a hybrid on-site focus in West Point, PA and regular site visits.

Qualifications

• Minimum 5 years' experience in CSV, CSA, Automation Compliance, Shopfloor, Enterprise, Lab and Quality Systems within a regulated pharmaceutical or biotechnology environment.

Responsibilities

• Lead CSV compliance activities for capital and strategic projects, ensuring adherence to regulatory requirements.
• Develop, review and approve validation deliverables per SOPs and CFR 21 Part 11.
• Provide guidance on SDLC, CSA, qualification and validation approaches to project teams.
• Participate in CSV compliance reviews and project meetings
• Assist with change controls and CSV-related risk assessments
• Maintain CSV trackers, metrics and reporting, ensuring accuracy.

Skills

CSV compliance

Computer System Validation

GAMP 5

21 CFR Part 11

EU GMP Annex 11

SDLC

Change Management

Deviation processes

Risk-based validation

CSA

Stakeholder management

Communication

Tools

DELTA V

PI Historian

PLC

Job description

Job Location - West Point, PA (Hybrid, must visit site 3 days a week)

Job Description-

• Lead CSV compliance activities for capital and strategic projects. Must have worked in CSV in Manufacturing automation systems like DELTA V, PI Historian, PLC, LAB Automation Systems (any one of the systems or all).
• Develop, Review and approve validation lifecycle deliverables in accordance with applicable SOPs and regulatory requirements, such as CFR 21 Part 11.
• Provide compliance guidance to project teams on SDLC, CSA, qualification, and validation approaches.
• Participate in project meetings and CSV compliance reviews.
• Assist with project change controls, and CSV compliance-related risk assessments.
• Maintain project CSV compliance trackers, metrics, and reporting.
• Approval of SDLC documents as technical unit
• Minimum 5 years' experience in Computer System Validation (CSV), CSA, Automation Compliance, Shopfloor, Enterprise, Lab and Quality Systems within a regulated pharmaceutical or biotechnology environment.

Strong knowledge of:

• GAMP 5
• FDA 21 CFR Part 11
• EU GMP Annex 11
• Risk-based validation and CSA principles
• Software Development Lifecycle (SDLC)
• Change Management and Deviation processes
• Experience supporting capital projects and GMP computerized systems.
• Strong stakeholder management and communication skills.
• Ability to work independently across multiple projects and sites.
• Role based in West Point, PA (Must visit site 3 days a week)
• Candidates will need to be legally authorized to live and work in the United States and be willing to commute to site approximately three days per week.