Validation Engineer
1 month ago
Responsibilities:
Develop and execute validation protocols (Installation Qualification - IQ, Operational Qualification - OQ, Performance Qualification - PQ) for equipment, processes, utilities, and systems in accordance with regulatory requirements.
Perform risk assessments to ensure validation processes meet FDA, EU, and other applicable regulatory standards.
Support product lifecycle activities including process validation, cleaning validation, and sterilization validation.
Generate comprehensive validation reports and obtain necessary approvals from quality and regulatory teams.
Lead equipment qualifications (User Requirement Specifications - URS, Factory Acceptance Testing - FAT, Site Acceptance Testing - SAT, IQ, OQ, PQ) for new and existing systems.
Review and approve validation documentation, deviations, and change controls.
Ensure validation activities align with current Good Manufacturing Practices (cGMP) requirements and industry best practices.
Collaborate closely with Quality Assurance and Engineering teams to resolve validation-related issues.
Drive continuous process improvement initiatives to optimize manufacturing processes.
Provide technical expertise during internal and external audits related to validation activities.
Qualifications & Experience:
Bachelor’s Degree in Engineering, Life Sciences, or a related field.
5-8 years of experience in validation within the Medical Device or Pharmaceutical industry.
Strong knowledge of FDA, EU regulations, ISO standards, and cGMP compliance.
Experience with equipment qualification and process validation (IQ/OQ/PQ).
Familiarity with risk management methodologies, including Failure Mode and Effects Analysis (FMEA).
Knowledge of validation software, data integrity principles, and 21 CFR Part 11 requirements.
Experience with electronic validation systems like KNEAT is advantageous.
Top Skills:
Proficiency in Equipment Qualification (IQ/OQ/PQ).
Expertise in Process Validation and Cleaning Validation.
Regulatory Compliance knowledge (FDA, ISO, cGMP).
Strong understanding of Risk Management (FMEA).
Ability to develop Validation Protocols and Reports.
Knowledge of Data Integrity and 21 CFR Part 11 Compliance.
Familiarity with Validation Software.
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