Job Title: Lead Validation Engineer (Medical Device Focus) W2 Contract Only

Location: Massachusetts (Onsite)

Project Overview:

I-Pharm is seeking a highly experienced Lead Validation Engineer to address a backlog of equipment validations related to packaging equipment (including fill-finish), printers, and scanners for a combination product. This role will transition to leading validation activities for 20 new and relocated pieces of equipment as part of a site expansion project in Massachusetts. This project supports a combination medical device where hydrogen peroxide solution is filled into vials as part of the fill-finish process.

Candidate Profile:

The ideal candidate will have 10-15 years of validation experience within a GMP environment, specifically in medical device operations. The candidate must demonstrate proven leadership in managing validation activities and working with cross-functional teams. The role requires a full-time, onsite commitment of 40-50 hours per week, with a 12-month contract starting ASAP.

Key Responsibilities:

• Technical Leadership:
• Provide leadership in validation activities, covering equipment, utilities, manufacturing, and packaging systems, specifically for medical devices.
• User Requirement Specifications (URS):
• Collaborate with cross-functional teams (manufacturing, facilities, quality, and regulatory) to develop detailed URS for both existing and new equipment.
• IQ, OQ, PQ Execution:
• Lead and oversee the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) phases for new and relocated equipment. Supervise senior engineers in hands-on execution of these tasks.
• Risk-Based Validation Approach:
• Implement a risk-based strategy to streamline testing, minimize redundant activities, and ensure documentation adheres to regulatory standards.
• Master Validation Plan:
• Develop, manage, and oversee the Master Validation Plan, coordinating efforts with vendors, contractors, and internal stakeholders to ensure project timelines are met.
• Compliance Documentation:
• Create and approve all validation protocols, reports, and supporting documentation in compliance with FDA and ISO regulatory standards for medical devices.
• Cross-Functional Collaboration:
• Engage with senior leadership and cross-functional teams to ensure validation activities align with the overall project goals, regulatory requirements, and business objectives.

Qualifications:

• 10-15 years of validation experience in the medical device or pharmaceutical industries, particularly with aseptic/sterile fill-finish operations.
• Proven leadership in managing complex validation projects and teams.
• Expertise in developing and executing IQ, OQ, PQ protocols for equipment and systems.
• Familiarity with combination product regulations and medical device quality systems (FDA 21 CFR Part 820, ISO 13485).
• Ability to communicate effectively with senior leadership and cross-functional stakeholders.
• Experience working in GMP environments and managing compliance with FDA, ISO, and other regulatory standards.

This role provides a unique opportunity to lead critical validation efforts in a fast-paced environment, driving both operational efficiency and regulatory compliance in a site expansion project.

-- No C2C available --