Computer System Validation (CSV) Manager

Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed. The Opportunity Praxis is hiring a Lead Computer System Validation Engineer to help shape how Computer System Validation is done as we scale. This is a builder role: you'll own validation strategy across our growing GxP technology portfolio, help develop our CSV capabilities and team, and challenge us to continuously improve how we apply modern, pragmatic, risk-based validation.

Position : Computer Systems Quality Assurance (CSQA) Location:Indianapolis, IN (Remote for now) Duration: 12+ Months Contract Must Have Skills: We are looking for CSQA profiles with below mandatory skills. IT CSV Validation of IT systemsIT QA / QA eCompliance ManagerExperience with Veeva Quality Docs, ServiceNow, JIRA and ALMPharma industry experience is mandatoryMedical device experience is good to haveSafety / PharmacovigilanceClinical trials management systemsGoogle Cloud Platform / GVP

Job Title: CSV Lead Location - Remote Mandatory Skills - LIMS Lab Vantage & CSV Job Summary: Experience in the Pharmaceutical, biotechnology with LIMS Labvantage related System Development Lifecyle in Computer System Validation Experience in FDA and/or Global regulated environment with good understanding of GxP standards and Risk based validation.Knowledge of FDA guidances and industry standards (i.e., GAMP)Experience in writing and executing documentation for all aspects of the validation deli

Title: GxP Systems Lead / PM - Pharma Location: Remote Ekman Associates is a management consulting firm that specializes in developing business, digital, and technology strategy, delivering solutions, and addressing human resource demands. Summary: We are currently seeking a GxP Systems Lead SME who is experienced, but equally important, very hands-on, execution-focused, and able to work with a strong sense of urgency. While this is a senior/experienced role, we are not looking for someone who p