Validation Engineer 4

Validation Engineer 4

Marlborough, MA - Onsite

6 Months

Day to day:

The Validation Engineer plans, executes, and documents validation activities to ensure that equipment, processes, methods, software, and systems used to manufacture and control in vitro diagnostic (IVD) medical devices are fit for their intended use and meet regulatory and quality system requirements. They will lead to the validation of legacy manufacturing processes and equipment, ensuring validated processes effectively control CTQs derived from ISO 14971 Risk Management documentation and applicable product specifications. This role supports compliance with ISO 13485, ISO 14971, EU IVDR (EU) 2017/746, FDA 21 CFR 820, and internal procedures through development and maintenance of robust validation protocols, reports, and lifecycle documentation.

• Develop and maintain validation plans (e.g., Master Validation Plan) for manufacturing, test methods, equipment, computerized systems, and cleaning processes used for IVD products.
• Define validation scope, acceptance criteria, sampling plans, and risk-based rationales aligned with ISO 14971.
• Develop and execute process validation protocols, including IQ/OQ/PQ, for new and legacy manufacturing processes and equipment; determine validation or re‑validation requirements as needed.
• Develop and execute Test Method Validation (TMV) and method validation/verification protocols (e.g., analytical, functional, diagnostic methods) in line with relevant standards and guidance (e.g., CLSI, ISO 15189 where applicable).
• Perform Measurement System Analysis (MSA) and statistical evaluation of test method capability, process capability, and method robustness.
• Conduct software/computerized system validation (CSV) for GxP‑relevant systems in accordance with regulatory expectations (e.g., GAMP 5).
• Coordinate and perform validation studies, ensuring protocol adherence, complete/accurate documentation, and appropriate data collection and analysis.
• Establish and maintain traceability between CTQs, risk controls, user requirements, design outputs, process parameters, and validation acceptance criteria.
• Collaborate with cross‑functional teams (e.g., Quality, Manufacturing Engineering, R&D, QC, Regulatory Affairs, IT) to ensure validation strategies reflect PFMEA outputs, process risks, and regulatory expectations.
• Support change control by assessing validation impact of design, process, equipment, software, or supplier changes, and defining revalidation or verification requirements.
• Prepare clear, concise validation reports summarizing methods, results, deviations, risk assessments, and conclusions.
• Provide validation and qualification expertise for cross‑functional projects, including new product introductions and process transfers, and train colleagues on validation principles, documentation, and regulatory expectations.
• Excellence through Integrity, Compliance, Safety and Environment
• Ensure compliance with all company policies and procedures, including safety regulations, Personal Protective Equipment (PPE) requirements, Standard Operating Procedures (SOPs), Quality Management System regulation (QMSR), ISO standards, and Good Documentation Practices (GDP).
• Demonstrate a strong commitment to the company's core values, including integrity, respect, collaboration, and innovation.
• Actively contributes to a positive and inclusive work environment, supporting colleagues and promoting a culture of mutual respect and teamwork.
• Participate in regular training and complete all training on time.

Required Skills:

• Bachelor’s degree or master’s degree in engineering (e.g., Biomedical, Chemical, Mechanical, Industrial) or related discipline, or equivalent combination of education and experience.       
• 10 years of validation experience in the Medical Device industry, or regulated manufacturing environments.
• Hands-on experience with IQ/OQ/PQ, method validation, and computerized system validation.
• Solid understanding of:
• IVD / medical device regulations and standards (e.g., IVDR, 21 CFR 820, ISO 13485, ISO 14971).
• Validation principles (process, equipment, method, software, cleaning).
• Risk management and design transfer concepts.
• Statistical methods used in validation (e.g., capability analysis, MSA, sampling plans).
• Strong technical writing skills for protocols, reports, and rationales.
• Detail-oriented, systematic, and data-driven.
• Strong technical writing, problem-solving and analytical skills.
• Ability to work independently, manage multiple projects, and meet deadlines in a regulated environment.