CSV Validation Lead: Manufacturing Automation (Hybrid)

Raas Infotek LTD; 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

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.