Compliance & CSV Consultant

We are looking for an experienced CSV and regulatory compliance consultant to support a GMP software remediation and validation project for a legacy PLC-based control system used in a regulated medical device and pharmaceutical environment. Project Background The system is a custom, Do-more Designer H2-DM1E PLC-based sterilization control system with a C-More HMI (Version 4.01), in continuous production use for over 10 years. The system currently has no audit trail, no user access controls, no password management, no electronic signatures, and no SDLC documentation — requiring full 21 CFR Part 11 compliance remediation. Scope of Work Stage 1: Gap Analysis & Risk Assessment including Software FMEA Stage 2: Remediation Planning & SDLC Framework (URS, FRS, Risk Management File, SOPs) Stage 3: Technical Remediation Support & Compliance Oversight Stage 4: IQ/OQ/PQ Validation Execution Stage 5: Closure, Training & SOP Finalization Required Skills & Experience Minimum 5 years hands-on CSV and 21 CFR Part 11 experience Experience with PLC-based systems in GMP environments Strong knowledge of ISPE GAMP 5, FDA QMSR, ISO 13485 Experience writing and executing IQ/OQ/PQ protocols FMEA and risk assessment experience SOP development and training delivery Ability to work independently and deliver on tight timelines Project Details Location: Remote Duration: 12 weeks Start: Immediate Budget: Please submit your hourly or fixed rate proposal Important Please include in your proposal: Relevant experience with PLC-based or legacy system CSV projects Your proposed rate (hourly or fixed per stage) Your availability to start immediately