Project Manager CSV, QMS, LIMS & ERP Validation - €400/day Outside IR-35 - Fully Remote

Pharma Experience Mandatory

ASAP Start

14 months

We are seeking an experienced Project Manager/Consultant with strong expertise in Computer Systems Validation (CSV) and regulated IT delivery, supporting the implementation and validation of enterprise systems including QMS, LIMS, and ERP platforms.

The successful candidate will lead cross-functional project teams to ensure systems are delivered in compliance with GxP, FDA, and ISO requirements, managing validation life cycle activities from planning through execution and audit readiness.

Key Responsibilities

• Lead end-to-end delivery of regulated IT projects involving QMS, LIMS, ERP, and other GxP-critical systems

• Manage CSV activities in line with GAMP 5, FDA 21 CFR Part 11, Annex 11, and internal quality standards

• Develop and maintain validation documentation including:

  • Validation Plans (VP)

  • URS, FRS, and design specifications

  • IQ/OQ/PQ protocols and reports

  • Risk assessments and traceability matrices

• Coordinate stakeholders across Quality, IT, Engineering, Manufacturing, and external vendors

• Ensure project milestones, timelines, and budgets are achieved while maintaining compliance

• Support audit and inspection readiness, including responding to regulatory findings

• Drive best practices for change control, deviation management, and system life cycle governance

• Provide consulting support on validation strategy and regulated system implementation

Required Experience & Skills

• Proven experience delivering projects in regulated environments (pharma, biotech, med devices)

• Strong background in CSV and validation of enterprise applications

• Hands-on experience with one or more of the following:

  • QMS systems (eg, TrackWise, Veeva, MasterControl)

  • LIMS platforms (eg, LabWare, STARLIMS)

  • ERP systems (eg, SAP, Oracle)

• Solid knowledge of compliance frameworks:

  • GAMP 5

  • FDA 21 CFR Part 11

  • EU Annex 11

  • ISO 13485/GMP requirements

• Excellent project leadership, stakeholder management, and documentation skills

Project Manager/Consultant - CSV, QMS, LIMS & ERP Validation

bluewaveSELECT is a global recruitment business exclusively focused on SAP and enterprise technology. Having placed over 4,000 SAP professionals, we have supported some of the most high-profile transformation programmes for leading organisations worldwide.

Our mission is to become the world's most trusted SAP recruitment business, delivering a unique wow factor by consistently exceeding expectations for both our customers and our network of consultants. As an official SAP partner, listed on the Ariba Network, and with a 5-star Trustpilot rating, we pride ourselves on quality, transparency, and long-term relationships. Whether this is your first engagement with bluewaveSELECT or you are a returning consultant, we look forward to working with you.