CSV Lead Consultant

Client is seeking a CSV Lead Consultant to support its legacy system modernization and ongoing validation initiatives. This role will focus primarily on Computer System Validation (CSV) but would greatly benefit from additional experience in equipment, process, aseptic, sterile/cleaning validation.

The ideal candidate will play a critical role in establishing structured validation processes, ensuring data integrity and compliance across manufacturing and quality systems. Given the current state: a 20+ year-old facility with aging processes, this consultant will be instrumental in supporting new implementations, data management strategies, and regulatory alignment as the company transitions toward MDR certification in the EU.

This is a fully onsite role in Bedford, MA (Monday Friday), requiring hands-on collaboration with stakeholders across Quality, Engineering, and Manufacturing. Responsibilities:

Lead Computer System Validation (CSV) efforts, ensuring compliance with FDA 21 CFR Part 11, GAMP 5, ISO 13485, and MDR regulations.

Develop and implement a structured CSV framework & SDLC Client lacks a robust CSV program and requires documentation strategies, validation plans, and qualification protocols from the ground up.

Support major system implementations & upgrades:

Ignition SCADA system deployment across multiple manufacturing lines.

PLC-driven systems & HMI replacement (currently no overarching system architecture).

Data historian implementation critical for long-term audit readiness and process monitoring.

Assess and document system gaps, aligning with MDR certification requirements for legacy products.

Develop validation documentation (VP, URS, IQ, OQ, PQ, RTM, etc.) to support software, equipment, and automation validation.

Ensure data integrity & compliance strategies are in place for batch records, GMP documentation, and audit readiness.

Provide strategic input on system architecture & data flow to optimize validation and compliance practices.

Collaborate with cross-functional teams (QA, Engineering, IT, Manufacturing) to drive validation projects to completion.

Manage validation timelines, task execution, and project tracking, ensuring deliverables meet deadlines. Requirements:

8+ years of CSV experience in regulated industries (medical device, pharma, or biotech).

Strong background in Computer System Validation (CSV) & Software Development Life Cycle (SDLC) experience building validation programs from scratch is a huge plus.

Experience with modernizing legacy systems ideal candidate has worked with aging infrastructures and helped transition organizations toward compliant, data-driven validation programs.

Hands-on experience with SCADA systems (Ignition preferred), PLC-driven automation, and HMI systems.

Knowledge of aseptic processing & sterilization validation (ISO 13408) is a plus, but not required.

Understanding of ISO 13485, 21 CFR Part 11, GAMP 5, and EU MDR compliance.

Ability to work cross-functionally with IT, Engineering, Manufacturing, and Quality teams.

Strong documentation and regulatory writing skills must be able to create clear, audit-ready validation protocols and reports.

Experience with validation tools like MasterControl, Empower, or other QMS/eQMS systems is a plus.

Proven ability to work independently in a fast-paced, evolving environment.