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(Contractor) Senior Computer Systems Validation Specialist

Date:  Mar 3, 2021
Location: 

Maryland Heights, MO, United States

About Curium

Curium is the world’s largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.

 

With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline ‘Life Forward’ represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.

 

Summary of Position

The Computer Systems Validation Specialist 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.  

Essential Functions
  • 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   
Requirements
  • Bachelor Degree in Science or Engineering discipline   
  • Experience in the laboratory instrument validation field including those with computerized systems attached in cGMP environment  
  • Proficiency with core computer software/systems (Word, Excel, Project, SharePoint, etc.)     

 

Working Conditions

  • 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  
Competencies
  • Results driven.
  • Ability to do simple to complex math calculations, input data into the computer and analyze data as required.  
  • Ability to multitask projects and work independently on long term tasks with minimal supervision, taking initiative to communicate details and issues to the team and management as appropriate. 
  • Excellent attention to detail is essential
  • Must be proficient in use of Microsoft suite office products; demonstrate good computer skills, including utilizing personal computers and data entry programs.
  • A GMP mindset and logical task completion approach.
  • Excellent writing and verbal communications skills.
  • Ability to work independently and with others to accomplish goals and priorities.
  • Proven ability in the development of methods and statistical evaluation data preferred.
  • Knowledge of regulatory and compendial guidelines concerning the establishment, validation and documentation of test procedures and equipment qualification and validation.
  • Strong desire to learn about and master niche analytical techniques, unique to laboratory testing in the nuclear medicine industry.

Disclaimer

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.

 


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