HAEMONETICS, THE Blood Management Company is a global leader engaged in the design, manufacture and worldwide sales and marketing of blood management solutions. Recognized as the innovator in blood technologies, our mission is to create innovative products, design information technology platforms and to provide consulting services to advance the safety, quality and availability of the world’s blood supply.
The Validation Specialist will be responsible for validating equipment, facilities, utilities, test methods, process and product at Haemonetics Puerto Rico. The scope includes development and execution of: Design Qualification, Validation plans, User and Functional requirements documents, IQ, OQ, PQ/PV and computer validation protocols. The resource needs to manage and execute small to medium size projects. Needs to be proficient writing SOP’s, manufacturing and supporting for validation cycle documents. The specialist will interact and provide support to corporate groups such as R&D, Advanced Engineering and Product Engineering. The resource will provide guidance and leadership in validation related topics. Needs to be a team player and provide support to manufacturing as required.
• Responsible for the development and execution of the projects Validation Master Plan.
• Develop of User Requirements and Functional specifications documentation for projects.
• Interact and support corporate groups such as R&D and Engineering related to new products, technologies and process improvements.
• Supports activities directed to maintain ISO 13485 and 9001Certifications.
• Provides training in topics, specifically on equipment, methods and manufacturing procedures.
• Performs Internal & Supplier audits related to Validation equipment and process.
• Provide support to internal/external audits related to validation documentation.
• Keep up to date an inventory of all product/process validations. Keep validation documentation organized and controlled in the controlled designated area.
• Supports manufacturing as required.
• Prepares and reviews SOP.
• Prepares protocols for IQ/OQ/PQ, as required, and Final Reports.
• Accountable for small to medium size Engineering projects.
• Write and execute computer validation protocols including Part 11 – Electronics records.
• Contributes to team effort by accomplishing established results; keeping business information confidential; administering the system security; ensuring data accuracy and integrity; maintaining updated professional and technical knowledge; assuring systems compliance with laws, regulations, and corporate standards.
• Provide technical review to protocols and report as required.
• Participate in the development of improvement projects including CIP’s and process improvements.
Education and Experience Required:
• Bachelor’s Degree in Science with major in Engineering, Physics, Biology, Microbiology or Chemistry.
• Over five (5) years of related experience in validations in Medical Devices, Biotechnology and/or Pharmaceutical industry preferably.
Haemonetics Corporation is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
Haemonetics Corp. - 20 months ago
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