Immucor, Inc. Validation Engineer III in Warren, New Jersey

Overview

We are seeking an experienced Validation Engineer III to support the development, implementation and maintenance of Immucor’s Global Validation program. In this position, you will lead our Global Validation team member(s) based at the Warren, NJ manufacturing site, while providing guidance to thosebased at our Waukesha, WI and Norcross, GA manufacturing sites.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.

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 III (Validation/Manufacturing)

Responsibilities

As a Validation Engineer III you will support the development, implementation, and maintenance of the Global Validation program across multiple manufacturing locations, according to written procedures and industry best practices. Additional responsibilities for this Validation Engineer III 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, spreadsheet, cleaning, sterilization, test method, process, and shipping 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 - 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.

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

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

  • Compliance - Remain up-to-date and ensure compliance with current industry trends as well as current Good Manufacturing Practices, Quality System Regulations, ISO13485, and other relevant regulations and standards. 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 III (Validation/Manufacturing)

Qualifications

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

Requirements for the Validation Engineer III role include:

  • Bachelor's Degree in related science/engineering discipline with 8+ years’ relevant validation experience or Master's Degree with 6+ years' relevant validation experience.

  • Master’s Degree in Biomedical or Chemical Engineering, preferred .

  • 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 Black Belt Certification, preferred .

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.

Validation Engineer III (Validation/Manufacturing)

Job ID 2018-1866

Category Engineering