Senior Validation Engineer
4 weeks ago
Senior Validation Engineer
RESPONSIBILITIES
- Leading start-up, commissioning, qualification, validation and revalidation projects for facility, equipment, critical utility, automation/computer system, cleaning, sterilization, medical device, and drug product manufacturing processes.
- Leading the delivery of validation within complex, capital projects overseeing engineering, quality, and compliance aspects of validation.
- Authoring, executing, and summarizing qualification and validation protocols.
- Conducting Risk / Impact assessments and establishing system boundaries.
- Ensuring protocols, records, and procedures are in compliance with current Good Manufacturing Practices (cGMP), industry standards and approved SOPs.
- Coordinating the investigation and impact assessment for all deviated equipment or processes discovered upon calibration or validation.
- Initiating and/or providing validation input on quality systems such as CAPAs and change controls.
- Responsible for other duties and projects as assigned.
RESPONSIBILITIES
- Minimum 8+ years of validation experience in pharmaceutical, medical device or FDA regulated environments.
- Strong understanding of cGMP and regulations related to facility, utility, equipment, and process validations.
- Ability to initiate, manage and close quality systems such as change control, CAPA and deviation management.
- Detailed experience performing root cause analysis investigations for deviations and non-conformances having technical scope.
- Excellent written and verbal communications skills.
- Solid understanding of quality risk management principles and statistical concepts as applicable to area of responsibility.
- Subject matter expert on regulations and best practices pertaining to validation.
- Practical application and knowledge of ISO 13485, GHTF Process Validation Guidance and other applicable standards used in the medical device manufacturing.
EDUCATION
- B.S. degree in Engineering or related discipline
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