Manufacturing Validation Engineer

Position Overview:
The Manufacturing Validation Engineer will play a pivotal role in ensuring the validation and qualification of manufacturing equipment, systems, and processes in compliance with industry regulations and company standards in the medical device sector. This position combines technical expertise in manufacturing equipment, quality assurance processes, and project management abilities to oversee validation activities from initiation to completion. The role requires a blend of engineering, regulatory knowledge, and leadership skills to drive successful project delivery, including documentation, risk management, and effective collaboration across cross-functional teams.
Key Responsibilities:
Plan, execute, and manage validation protocols for manufacturing equipment, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) to ensure compliance with regulatory standards (FDA, ISO 13485, etc.).
Lead the qualification of new and existing manufacturing equipment to ensure proper installation, performance, and consistent functionality.
Ensure compliance with current Good Manufacturing Practices (cGMP) and other relevant standards throughout validation processes.
Provide technical expertise on equipment, ensuring that systems and tools meet necessary specifications, performance criteria, and operational requirements.
Lead root cause analysis and troubleshooting efforts when equipment issues arise during validation, identifying corrective and preventive actions (CAPA).
Develop and review validation protocols, reports, and SOPs (Standard Operating Procedures) to ensure all activities are properly documented and compliant with regulatory requirements.
Ensure the traceability and audit readiness of all validation activities , supporting internal audits and regulatory inspections.
Support the creation and review of regulatory filings and submissions as required.
Ensure proper documentation practices , maintaining the highest standards for data integrity and quality assurance throughout the validation process.
Actively participate in continuous improvement efforts within the manufacturing area to optimize equipment performance, reduce waste, and enhance operational efficiency.
Provide training and mentorship to junior engineers or technicians, guiding them through validation protocols, equipment troubleshooting, and best practices.
Contribute to lessons learned meetings and share insights to improve future validation processes.
Lead and manage validation projects from conception through to completion, ensuring all aspects of the project adhere to defined timelines, budgets, and quality standards.
Develop project timelines and schedules , ensuring all milestones are met and delivering the required project updates to senior management and stakeholders.
Coordinate cross-functional teams, including Engineering, Quality Assurance, Manufacturing, Regulatory Affairs, and Suppliers, to ensure the success of validation projects.
Conduct risk assessments for validation activities and ensure mitigation plans are in place.
Track and report on the progress of validation projects and proactively address any potential delays or risks to project timelines.
Prepare and maintain validation documentation and ensure compliance with company standards, including change control documentation, project status reports, and validation summaries.
Skills:
Bachelor’s or Master’s degree in Engineering, Mechanical Engineering, Industrial Engineering, or a related field.
5+ years of experience in manufacturing equipment validation, qualification, or a related engineering role within the medical device or pharmaceutical industry .
At least 2 years of experience in project management, leading cross-functional teams and driving complex projects to completion in a regulated environment.
Familiarity with regulatory standards such as FDA 21 CFR Part 820, ISO 13485, and cGMP.
Expertise in validation practices (IQ/OQ/PQ) and associated documentation.
Hands-on experience with manufacturing systems and equipment used in medical device production.
Strong project management skills including the ability to create project timelines, track progress, and mitigate risks. PMP certification is a plus.
Strong analytical and problem-solving skills , including root cause analysis and CAPA management.
Ability to work collaboratively in a cross-functional team environment .
Excellent communication skills, both written and verbal, with the ability to prepare detailed reports and present findings to management.
Knowledge of industry-specific software , such as LIMS (Laboratory Information Management Systems), ERP (Enterprise Resource Planning), or Veeva Vault, is a plus.
Familiarity with risk management principles (e.g., FMEA, Risk Assessment) and their application in equipment validation.
Skills:
validation manufacturing IQOQPQ Equipment qualification risk assessment verification manufacturing engineer

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