Log In
Sign Up
Job Description
Overview
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.
We are seeking an experienced Senior Validation Engineer to support the development, implementation, performance, global harmonization and maintenance of the validation program across multiple manufacturing locations, according to written procedures and industry best practices. This position will also serve as a key problem solver and a potential core team leader to conceive, 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
Responsibilities of the Senior Validation Engineer include:
-
Supporting the establishment, reporting, and achievement of performance metrics and objectives representative of an industry-leading Validation Program
-
Ensuring consistent, on-time completion of training assignments
-
Pursuing opportunities to develop further expertise on facility, equipment, software, cleaning, test method, and process validation
-
Pursuing opportunities to develop further expertise on design of experiments studies and commissioning activities (factory acceptance test/ site acceptance test)
-
Training and mentoring contractors and other staff within your area(s) of expertise, including peer review and/or approval of related documents
-
Ensuring assigned projects are completed within approved timeliness and budgets
-
Supporting the establishment of project priorities and effectively adapting to change in direction based upon business needs
-
Maintaining consistent communication with internal customers and stakeholders on changes in priority, status and time-line
-
Supporting the establishment and maintenance of the department culture in line with the company’s core values
-
Interacting cooperatively with co-workers and management of other departments and receiving direction well from superiors
-
Developing and executing engineering and validation strategies, plans, and protocols for assigned regulatory compliance, change control, and design control projects, including Operations continuous improvements and technical transfers
-
Writing and processing documents through company systems
-
Remaining up-to-date and ensuring compliance with current industry trends as well as Quality Systems, ISO13485, cGMP and other relevant regulatory protocols
-
Providing support for internal and external audits and Quality System investigations
-
Creating and revising SOPs supporting Validation Program functions and activities
Senior Validation Engineer (Engineering)
Qualifications
Qualifications for the Senior Validation Engineer role include:
-
Bachelor’s degree in Biomedical Engineering, Chemical Engineering or related science/engineering discipline
-
With 5+ years validation experience
-
OR equivalent combination of education and experience such as:
-
Master’s with 3+ years validation experience
-
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
-
Experience leading cross-functional process and equipment improvement projects from concept through design 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.
Immucor offers a comprehensive benefits package available on the start date of your employment, including:
-
Medical, prescription, dental, and vision insurance – we offer multiple plan options so you can determine which best suits your needs and the needs of your dependents
-
Wellness program
-
STD/LTD/Life insurance all 100% company paid
-
Voluntary life/accident/hospital indemnity insurance for yourself, spouse/domestic partner and dependents
-
Tuition reimbursement
-
Company matched 401k plan
-
Vacation/Company & Personal Holidays/Sick days
Where permitted by applicable law, must be fully vaccinated against COVID or have an approved Immucor exemption. Proof of vaccination status will be required on first day of employment.
Job Locations US-GA-Norcross
Job ID 2022-3099
Category Engineering
Immucor is an Equal Opportunity/Affirmative Action Employer; Minority/Female/Disability/Vet; Drug Free Workplace