Immucor, Inc. Validation Engineer II in Norcross, Georgia

Overview

We are seeking an experienced Validation Engineer to support the development, implementation, and maintenance of Immucor's global validation program. This position may provide remote support to write/approve documents for other main sites, such as Warren, NJ and/or Waukesha, WI. 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!

Founded in 1982 and based in Norcross, GA, Immucor is a global leader in transfusion and transplantation diagnostics that facilitate patient/donor compatibility worldwide. Our mission is to ensure that patients in need of blood, organs, or stem cells get the right match that is safe, accessible, and affordable. The result is life changing for a patient in need of a transfusion or transplant. 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.

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 .

Validation Engineer II (Validations/Manufacturing)

Responsibilities

As a Validation Engineer II you will support the development, implementation, and maintenance of Immucor's global validation program,according to written procedures and industry best practices.Additional responsibilities for this Validation Engineer II role include:

  • Program Metrics & 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 develop further expertise on facility, equipment, software, spreadsheet, cleaning, test method, and process validation. Train and mentor contractors and other validation staff within your area(s) of expertise, including peer review and/or approval of related documents.

  • Project Management - 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.

  • Validation Planning & Execution - Develop and execute validation strategies, plans, and protocols for assigned projects, including new product development, new process development and improvements, product and process transfers, base business compliance, and change controls.

  • 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 System Regulations, ISO13485, cGMP and other relevant regulations. Provide support for internal and external audits and Quality System investigations.

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

Validation Engineer II (Validations/Manufacturing)

Qualifications

As a Validation Engineer II, you must have the necessary competencies required for this position. The ideal Validation Engineer II candidate will have broad experience developing and executing validation strategies, plans, and protocols, to include facility, equipment, software, spreadsheet, cleaning, test method, and process validation. In addition, experience developing and executing validation strategies, plans, and protocols, in support of new product development, new process development and improvements, product and process transfers, base business compliance, and change controls.

Requirements for the Validation Engineer II 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 Docotate with 1+ years' validation experince

  • 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 .

  • Six Sigma Green Belt Certification, preferred .

Validation Engineer II (Validations/Manufacturing)

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 ID 2018-1815

Category Engineering