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Sr. Computer system Validation Engineer

Saint Joseph, MO 64506

Posted: 02/13/2025 Employment Type: Contract Job Category: Technology Job Number: 617003 Is job remote?: No Country: United States

Job Description


Job Description
  • Validation documentation Authoring (validation plans, user requirements specifications, risk assessment, IQ-OQ-PQ protocols, trace matrix and summary reports)
  • Experience in validating GMP Lab systems and Equipment
  • Responsible for assuring a system/application meets its requirements as outlined in system specification (URS/FRS) per process defined in the Validation Plan for the project.
  • Identify and escalate, as necessary project risks and issues to the CSVC Manager.
  • Engage in multiple CSVC projects through the assimilation of data, establishing facts and drawing valid conclusions to deliver results in accordance with resources, constraints and business needs.
  • Be able to prepare reports on defects and problems that arise during system testing.
  • Have solid oral and written communication skills and teamwork skills.
  • Be a good team player, able to meet deadlines and handle changing priorities.
  • Have strong judgment capabilities to clarify requirements when necessary.
  • Have the ability to work with cross functional teams
  • Have solid experience working with validated systems.
  • Work with business representatives to ensure the test cases reflect business rules and processes.
  • Fulfills a subject matter expert role(s) for critical quality and compliance GxP end-use applications supporting Animal Health business processes.

Skills:    
Required Experience 
  • GMP/Regulated lab, more than 5 years of CSV experience required.
  • Technical writing Experience
  • Highly skilled in Computerized System testing and validation in the healthcare industry.
  • Knowledge of GxP regulations (e.g. 21 CFR Part 11, Annex 11)
  • Solid project organizational skills. Ability to multi-task.
  • Must have strong analytical problem-solving skills. 
  • Excellent communication including written, verbal, and listening skills.
  • Self-motivated, detail oriented, takes initiative and ability to work independently without close supervision.

Education:    
  • BS in Science or Technical Writing Degree





Pay Rate Range: $65-80/hr depending on experience 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Saint Joseph, MO

Discover exciting job opportunities in the bustling area around Saint Joseph, Missouri! Nestled along the Missouri River, this vibrant region offers a perfect blend of small-town charm and big-city amenities. With a thriving economy, diverse industries, and a welcoming community, Saint Joseph provides endless growth prospects for job seekers. Explore positions in healthcare, education, manufacturing, and more in a region known for its rich history, including landmarks like the Pony Express Museum and the Jesse James Home. Indulge in local delicacies like the famous Kansas City-style BBQ or catch a show at the historic Missouri Theatre. With scenic parks, such as Krug Park, and a variety of recreational activities, Saint Joseph is a hidden gem just waiting for you to make your mark. Start your career journey here today!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.