Remote Work - need CSV Engineer

Job Title: CSV Engineer

Location (on site vs remote): REMOTE

Duration: 6 Month Contract to Hire

Visa Statuses Accepted: USC OR GC ONLY

Interview Process: 2-3 MS Teams Interviews

IT CSV Engineering Job Descriptions

Phibro is a trusted partner delivering a comprehensive portfolio of animal health solutions and unmatched support. Our research and development team continually works on discoveries to improve the health and welfare of animals, helping ensure the success of farmers & ranchers around the world. Phibro provides a broad range of proven products for all species, including vaccines, medicated feed additives and animal nutrition and mineral products.

The CSV Engineering has a primary focus to partner with the Business and System Owners, Quality, and the Global IT Computer Systems Validation (CSV) Director to define and execute Phibro ERP and Manufacturing System’s Validation with strong risk-based approach, support internal and external audits, and identify opportunities to improve Phibro’s CSV methodology.

Responsible for quality oversight of validation/qualification efforts supporting computerized systems (including equipment/instruments with a computer component) ensuring compliance to quality objectives and regulatory requirements. Works on problems that are complex in scope where analysis of situations or data requires in-depth evaluation of various factors. Exercises judgement within defined practices and policies in selecting methods, techniques, and evaluation criteria for resolving problems and obtaining results.

This leadership position reports to the CSV Manager and Operations and will work closely with the other members of the organization to meet the program's goals.

Responsibilities

• CSV Engineering, including organizing and prioritizing daily tasks, performing training, and writing performance reviews.
• Provides IT CSV oversight for GXP computerized systems and applies risk-based methodology to validation/qualification efforts in compliance with 21 CFR Part 11, EU Annex 11, and GAMP.
• Provides IT CSV oversight of deviations, CAPAs, and change controls related to GXP computerized systems.
• Review and create validation documentation - such as user requirements functional requirements, validation plans, IQ/OQ/PQ documentation, risk assessments and VSR’s.
• Analyses, develops, tests, and deploys configuration, workflow, and/or reporting to improve the overall accuracy, efficiency, and effectiveness of the electronic computerized system.
• Effectively identifies and resolves system issues and appropriately communicates gating items to senior management and stakeholders.
• Review and audit CSV for IT systems according to 21 CFR Part 11, Annex 11, and other regulatory requirements.
• Participate in the development and improvement Quality Assurance programs, policies, processes, procedures, and controls ensuring compliance with current Good Manufacturing Practices (cGMP) expectations and established agency requirements/guidelines.
• Supports the external audit program for vendors related to GXP computerized systems.
• Participates in cross-functional project teams.
• May support and interface with regulatory agencies as required in support of regulatory agency inspections.
  
  

Job Skills Requirements

• Bachelor’s degree or equivalent experience.
• Substantial experience in CSV of GCP/GLP/GCLP/PVQA eSystems.
• Prior experience in leading or managing CSV projects.
• Experience supporting regulatory inspections.
• Experience with JDE and Veeva preferred.