- Manage start-up, commissioning, qualification, validation, and revalidation projects for various processes including facility, equipment, critical utility, automation/computer systems, cleaning, sterilization, medical devices, and drug product manufacturing.
- Oversee the delivery of validation in complex, capital projects, ensuring adherence to engineering, quality, and compliance standards.
- Create, execute, and summarize qualification and validation protocols.
- Perform risk and impact assessments, defining system boundaries.
- Ensure protocols, records, and procedures meet current Good Manufacturing Practices (cGMP), industry standards, and approved SOPs.
- Coordinate investigation and impact assessment for any deviated equipment or processes identified during calibration or validation.
- Provide validation input for quality systems such as CAPAs and change controls.
- Undertake other assigned duties and projects.
- Minimum 5-8 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 with a technical scope.
- Excellent written and verbal communication skills.
- Solid understanding of quality risk management principles and statistical concepts applicable to the 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 medical device manufacturing.
- Bachelor's degree in an engineering discipline.
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Validation Specialist - Lexington, United States - a Medical Device Equipment located in near Lexington, MA
Description
Job Duties:
Qualifications:
Education:
