What are the responsibilities and job description for the Computer system validation Engineer position at Grove Technical Resources, INC?
Job Title: CSV Lead Consultant
Location: Bedford, MA (Fully Onsite)
Duration: 6 months, potential to extend
Type: W2/1099 contract
Overview:
Seeking a CSV Lead Consultant to establish a structured validation framework for a legacy system modernization in a medical device manufacturing facility. The role involves Computer System Validation (CSV), SDLC implementation, and regulatory compliance (ISO 13485, FDA 21 CFR Part 11, GAMP 5, EU MDR).
Key Responsibilities:
• Lead CSV efforts for manufacturing and quality systems.
• Develop SDLC framework, and validation documentation (VP, URS, IQ, OQ, PQ, RTM, etc.).
• Support SCADA system deployment (Ignition preferred), PLC & HMI replacements, and data historian implementation.
• Ensure data integrity, GMP compliance, and audit readiness.
• Collaborate with QA, Engineering, IT, and Manufacturing teams.
• Manage validation timelines, execution, and tracking.
Qualifications:
• 8 years of CSV experience in medical devices, pharma, or biotech.
• Expertise in legacy system modernization & validation program development.
• Hands-on experience with SCADA (Ignition preferred), PLC-driven automation, and HMI systems.
• Strong understanding of ISO 13485, 21 CFR Part 11, GAMP 5, and EU MDR.
• Technical writing, project management, and cross-functional collaboration skills.
• Experience with QMS/eQMS tools (MasterControl, Empower) is a plus.
