Manufacturing Validation Engineer

Fusion Life Sciences Technologies LLC; Raynham (MA); On-site; USD 90,000 - 115,000; Full time

Job summary

Fusion Life Sciences Technologies LLC in the United States seeks a Manufacturing Validation Engineer to develop and validate manufacturing processes for new products and capacity expansion in a regulated medical device environment.

You will author URS, FAT/SAT, IQ/OQ/PQ, support change control, risk assessments, and continuous improvement while coordinating with suppliers and internal teams to ensure FDA and ISO compliance and data integrity.

Responsibilities

• Develop and implement manufacturing technologies for new products and capacity expansion.
• Design processes and equipment for manufacturability, quality, and regulatory compliance.
• Lead engineering activities in cross-functional project plans.
• Author and execute validation lifecycle documentation (URS, FAT, IQ, OQ, PQ).
• Coordinate qualification and commissioning of equipment, systems, and software.
• Support change control, deviations, root cause analysis, and continuous improvement.
• Review drawings and vendor docs to verify compliance with requirements.
• Ensure FDA, ISO, GMP, and data integrity compliance.

Job description

Title : Manufacturing Validation Engineer

Duration: 12 Months Contract

Description

• Develop and implement advanced manufacturing technologies to support new product introductions, site capacity expansion, and transformational initiatives within a regulated medical device manufacturing environment.
• Design manufacturing processes and equipment solutions to ensure manufacturability, scalability, quality, and regulatory compliance from concept through process qualification and commercial release.
• Lead engineering activities and deliverables in support of cross-functional project plans, ensuring alignment with project scope, timelines, and business objectives.
• Author, review, and execute validation lifecycle documentation including User Requirements Specifications (URS), Risk Assessments, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Develop and maintain manufacturing procedures, work instructions, process specifications, and supporting documentation to ensure standardized and compliant operations.
• Coordinate qualification and commissioning activities for manufacturing equipment, automation systems, utilities, and supporting software applications.
• Interface with internal stakeholders and external suppliers to resolve technical issues, manage project deliverables, support equipment implementation, and drive successful project execution.
• Support change control, deviation investigations, root cause analysis, risk assessments, and continuous improvement initiatives to enhance manufacturing performance and product quality.
• Review technical drawings, equipment designs, and vendor documentation to verify compliance with approved requirements and quality standards.
• Ensure compliance with FDA regulations, ISO standards, GMP requirements, quality system procedures, environmental health and safety requirements, and data integrity principles.