Manufacturing Engineer

About the Company

NovintiX is a rapidly expanding firm specializing in engineering and digital transformation services, catering to prominent clients in Life Sciences, MedTech, and Healthcare sectors across the US, Ireland, and Europe. The company delivers impactful digital initiatives, engineering expertise, and talent solutions designed to accelerate innovation, operational efficiency, and regulatory compliance.

Position Overview

The Manufacturing Engineer plays an essential role in validating and qualifying manufacturing equipment, systems, and processes to comply with industry regulations and internal quality standards within the medical device sector. This role demands a blend of technical knowledge, regulatory understanding, and leadership to manage validation activities end-to-end, including documentation, risk management, and collaboration across multiple teams.

Key Responsibilities

• Develop, execute, and oversee validation protocols such as Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing machinery to align with regulations like FDA and ISO 13485.
• Lead qualification procedures for both new and existing production equipment ensuring correct installation and reliable operation.
• Maintain compliance with current Good Manufacturing Practices (cGMP) throughout all validation activities.
• Offer technical guidance concerning equipment specifications, ensuring adherence to performance and operational metrics.
• Perform root cause analyses and troubleshooting on equipment issues during validation, implementing corrective and preventive actions (CAPA).
• Draft and review validation protocols, reports, and Standard Operating Procedures (SOPs) to guarantee thorough and compliant documentation.
• Ensure all validation efforts are traceable and ready for audit, supporting internal checks and external regulatory inspections.
• Assist with the preparation and evaluation of regulatory filings and submissions when needed.
• Uphold rigorous documentation standards to safeguard data integrity and quality assurance throughout validation.
• Engage in continuous improvement initiatives to enhance manufacturing equipment performance, minimize waste, and boost operational productivity.
• Provide mentorship and training to junior engineers or technicians on validation procedures, equipment troubleshooting, and best practices.
• Participate in lessons learned sessions to inform and refine future validation processes.
• Manage validation projects from conception through completion, ensuring adherence to schedule, budget, and quality benchmarks.
• Create and maintain project schedules, monitoring milestones and communicating progress to senior leadership and stakeholders.
• Coordinate with cross-functional departments including Engineering, Quality Assurance, Manufacturing, Regulatory Affairs, and suppliers to ensure project success.
• Conduct risk assessments related to validation activities and establish mitigation strategies.
• Monitor and report project status, anticipating and addressing risks or delays proactively.
• Prepare and maintain all validation-related documentation, including change control, status reports, and summary records, compliant with company standards.

Required Skills and Qualifications

• Bachelor’s or Master’s degree in Engineering, Mechanical Engineering, Industrial Engineering, or a related discipline.
• Two to three years of practical experience in validating manufacturing equipment within medical device or pharmaceutical sectors.
• Minimum of two years managing projects, leading cross-disciplinary teams, and delivering complex initiatives in regulated environments.
• Familiarity with regulatory frameworks such as FDA 21 CFR Part 820, ISO 13485, and cGMP.
• Expertise in validation methodologies including IQ, OQ, and PQ, along with comprehensive documentation skills.
• Hands-on experience handling manufacturing equipment utilized in medical device production.
• Strong project management capabilities including timeline creation, progress tracking, and risk mitigation; PMP certification is advantageous.
• Advanced analytical and problem-solving skills, particularly in root cause analysis and CAPA management.
• Proven ability to work effectively within multidisciplinary teams.
• Excellent verbal and written communication proficiencies for report generation and presentation to management.
• Knowledge of industry-related software such as Laboratory Information Management Systems (LIMS), Enterprise Resource Planning (ERP) systems, or Veeva Vault is favorable.
• Understanding of risk management tools like FMEA and risk assessment applied in equipment validation contexts.