Manufacturing Validation Engineer Role Overview
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The Manufacturing Validation Engineer plays a pivotal role in ensuring the validation and qualification of manufacturing equipment, systems, and processes align with industry regulations and company standards in the medical device sector.
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This position combines technical expertise in manufacturing equipment, quality assurance processes, and project management abilities to oversee validation activities from initiation to completion.
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The ideal candidate possesses 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.
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Key Responsibilities:
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* 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.
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* Lead the qualification of new and existing manufacturing equipment to ensure proper installation, performance, and consistent functionality.
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* Ensure compliance with current Good Manufacturing Practices (c GMP) and other relevant standards throughout validation processes.
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* Provide technical expertise on equipment, ensuring that systems and tools meet necessary specifications, performance criteria, and operational requirements.
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Required Skills and Qualifications:
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* Bachelor's or Master's degree in Engineering, Mechanical Engineering, Industrial Engineering, or a related field.
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* 5+ years of experience in manufacturing equipment validation, qualification, or a related engineering role within the medical device or pharmaceutical industry.
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* At least 2 years of experience in project management, leading cross-functional teams, and driving complex projects to completion in a regulated environment.
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* Familiarity with regulatory standards such as FDA 21 CFR Part 820, ISO 13485, and c GMP.
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Benefits:
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* Strong project management skills, including the ability to create project timelines, track progress, and mitigate risks.
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* Excellent communication skills, both written and verbal, with the ability to prepare detailed reports and present findings to management.
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* Hands-on experience with manufacturing systems and equipment used in medical device production.
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Other Requirements:
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* Knowledge of industry-specific software, such as LIMS (Laboratory Information Management Systems), ERP (Enterprise Resource Planning), or Veeva Vault.
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* Ability to work collaboratively in a cross-functional team environment.
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* PMP certification is a plus.
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