CSV Specialist (Onsite / St. Joseph, MO)

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

​** No 3rd-party submittals**

• 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 o 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. o 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. o Have strong judgment capabilities to clarify requirements when necessary.
• Have the ability to work with cross functional teams o 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.

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