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Immucor, Inc. Senior Validation Engineer in Norcross, Georgia

Overview

Founded in 1982 and based in Norcross, GA,Immucor is dedicated to offering products that enable patients anywhere who are in need of blood or an organ to receive the right match that is safe, accessible and affordable.The result is life changing for a patient in need of a transfusion or transplant.Immucor is a leading provider of transfusion and transplantation diagnostic products worldwide.Our new corporate identity illustrates the right match of donors with patients in need of blood or an organ as well as Immucor’s partnership with healthcare organizations in need of innovation and productivity. With the right match, we can transform a life together.

We are seeking an experienced engineer to support the development, implementation, performance, global harmonization and maintenance of Immucor’s Global Validation program across multiple manufacturing locations, according to written procedures and industry best practices. This role will additionally serve as a key problem solver and a potential core team leader to plan and lead cross-functional process and equipment improvement projects from concept through design and into Manufacturing.If you are interested in joining an organization where your talents and expertise will be highly appreciated, and if you meet our qualifications to excel in this position, we want to hear from you. Contact us today!

This position is not eligible for sponsorship for work authorization by Immucor, Inc. Therefore, if you will require sponsorship from us for work authorization now or in the future, we cannot consider your application at this time .

Senior Validation Engineer (Engineering)

Responsibilities

As a Senior Validation Engineer your responsibilities include:

  • Program Metrics and Objectives - Support the establishment, reporting, and achievement of performance metrics and objectives representative of an industry leading Validation Program.

  • Training & Mentorship - Ensure consistent on-time completion of training assignments. Pursue opportunities to develop further expertise on facility, equipment, software, spreadsheet, cleaning, test method, and process validation.Pursue opportunities to develop further expertise on design of experiments studies and commissioning activities (factory acceptance test/ site acceptance test).Train and mentor contractors and other staff within your area(s) of expertise, including peer review and/or approval of related documents.

  • Project Management - Ensure assigned projects are completed within approved timelines and budgets. Support the establishment of project priorities and effectively adapt to changes in direction based upon business needs. Maintain consistent communication with internal customers and stakeholders on changes in priority, status and timeline.

  • Company Culture - Support the establishment and maintenance of the department culture in line with the company’s core values. Interact cooperatively with co-workers and management of other departments and receive direction well from superiors.

  • Project Planning & Execution – Develop and execute engineering and validation strategies, plans, and protocols for assigned regulatory compliance, change control, and design control projects, including Operations continuous improvements and technical transfers.

  • Document Management - Write documents and process through company systems.

  • Compliance - Remain up-to-date and ensure compliance with current industry trends as well as Quality Systems, ISO13485, cGMP and other relevant regulatory protocols.Provide support for internal and external audits and Quality System investigations.

  • Validation Procedures - Create and revise SOPs supporting Validation Program functions and activities.

Senior Validation Engineer (Engineering)

Qualifications

The ideal candidate will have broad experience developing and executing engineering and validation strategies, plans, and protocols to include design of experiments studies and commissioning activities (FAT/SAT), in addition to facility, equipment, software, spreadsheet, cleaning, test method, and process validation.

Qualifications for this role include:

  • Bachelor's degree in Biomedical Engineering, Chemical Engineering or related science/engineering discipline

  • With 5+ years’ validation experience

  • OR Master's with 3+ years' validation experience

  • OR Doctorate with 1+ years' validation experience

  • Experience in the biotechnology industry or another similarly regulated industry (i.e. medical device, pharmaceutical)

  • Validation experience within blood banking and/or transfusion medicine and immunodiagnostics, preferred

  • Experienceleading cross-functional process and equipment improvement projects from concept through design and into Manufacturing, preferred

  • Six Sigma Green Belt Certification, preferred

Senior Validation Engineer (Engineering)

IMMUCOR, INC IS AN EQUAL OPPORTUNITY/AFFIRMATIVE ACTION EMPLOYER; MINORITY/FEMALE/DISABILITY/VETS; DRUG FREE WORKPLACE

RESUMES SUBMITTED TO IMMUCOR FROM THIRD PARTY RECRUITMENT FIRMS WILL NOT BE CONSIDERED.

This position is not eligible for sponsorship for work authorization by Immucor, Inc. Therefore, if you will require sponsorship from us for work authorization now or in the future, we cannot consider your application at this time.

Job Locations US-GA-Norcross

Job ID 2020-2427

Category Engineering


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