Posted on 11th November 2019
Computer Systems Validation Engineer – Contract (2 positions)
Curium was formed in 2017 through the union of IBA Molecular and Mallinckrodt Nuclear Medicine LLC. Curium is a world-class nuclear medicine solutions provider with over 100 years of combined industry experience. We are proud to service over 14 million patients worldwide each year and strive to provide best-in-class quality products and exceptional, reliable service.
Our diverse group of industry experts is unified under one strong and singular focus – to develop, manufacture and supply SPECT, PET and therapeutic radiopharmaceuticals to customers around the globe. In fact, we have over 6,000 customers in over 70 countries world-wide.
At Curium, every single dose counts in helping doctors and patients diagnose and treat disease. That means every single employee counts toward meeting this unified objective to help each patient live “Life Forward”. We have an amazing team that lives by our core values every single day – integrity, commitment and collaboration. Come grow with us!
Summary of Position
The Computer Systems Validation Engineer will provide validation support for computerized systems, software, and IT infrastructure that have been newly installed, upgraded, replaced and / or modified in a cGMP Manufacturing Facility.
- Author cGMP risk assessments, user requirements and functional specifications, validation plans, qualification test protocols (i.e. IQ, OQ, PQ), reports, addendums and other validation efforts as required
- Perform computer systems validation activities as they pertain to SDLC, including project planning, developing validation strategies, document development and document reviews
- Ensure adherence to national and international regulatory guidelines on Electronic Records and Electronic Signatures and Data Integrity, cGMP, FDA 21 CFR Part 11/210/211, EU Annex 11, MHRA and GAMP5 guidelines
- All other responsibilities as assigned with or without accommodation
- Bachelor Degree in Science or Engineering discipline
- Experience in the laborartory instrument validation field including those with computerized systems attached in cGMP environment
- Proficiency with core computer software/systems (Word, Excel, Project, SharePoint, etc.)
- Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels
- Must be willing to wear a variety of personal protective equipment
- May be required to sit or stand for long periods of time while performing duties
- Responsibilities also include the ability to lift, walk, bend, stoop, push, pull, reach, and climb stairs without accommodation
- Must possess good hand-eye coordination
- Some gowning may be required to enter laboratory areas
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
Equal Opportunity Employer
Curium is an equal opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.