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DI CSV Validation Engineer

3 months ago

Western Springs, United States ProPharma Group Full time

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. As the world's largest RCO (Research Consulting Organization), 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.

The DI Val CSV Engineer III position is responsible for performing Computer System Validation (CSV) projects and providing consulting and contract services to clients under the guidance of more experienced CSV professionals.

Essential Functions

  • Participate on teams of internal resources in delivery of CSV projects.
  • Author functional requirements specifications that are complete, accurate, and testable
  • Author system Risk Assessments, 21 CFR 11 Assessments, and Annex 11 Assessments
  • Author Validation Plans and Validation Reports
  • Author validation and verification testing protocols/scripts (i.e., IQ, OQ, PQ) and Trace Matrices
  • Execute validation and verification testing protocols and document results
  • Author SOPs for User Operation, System Administration and Maintenance, Back-up/Recovery, and Audit Trail Review
  • Prepare project status reports for clients and ProPharma management
  • Extensive travel may be required at times.
  • Other duties as assigned.
Necessary Skills and Experience
  • Experience in the validation at least two of these computer system categories: automation control, laboratory systems, quality management systems, ERPs, clinical trial and pharmacovigilance applications.
  • Experience in validation of multiple system delivery models including SaaS, PaaS, IaaS, and On Prem.
  • Working knowledge of software testing techniques and test case development best practices.
  • Working knowledge of FDA 21 CFR 11, EU Annex 11 and supporting guidance documents.
  • Working knowledge of industry best practices such as GAMP5, ANSI standards (S-95, S-88), and ASTM (E2500).
  • Able to work effectively with local and virtual team members and other professionals, such as QA specialists, software developers, and system users.
  • Effective written and oral communication skills; ability to write, type, express or exchange ideas of a technical nature by means of the spoken word; convey information/instructions accurately; receive detailed information through oral or written forms and to translate those instructions into physical execution of tasks.
Educational Requirements
  • AS or B.S./B.A. in Software Engineering, Computer Science, Information Technology, or a related field.
Experience Requirements
  • Minimum 5 years of experience in the field of Computer System Validation.
  • Minimum 2 years of experience in Pharmaceutical, Medical Device, Clinical Research, or Healthcare Industries.


We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***