$80K — $100K *
As part of an overall cross functional Software Development Lifecycle (SDLC) approach to computer systems compliance and validation, the Computer Systems Validation (CSV) Specialist will be involved in all aspects of computer systems validation and qualification within a GxP regulated environment.
Under the general guidance of the CSV Lead and the direction of Sr. CSV Specialists, the CSV Specialist will be involved in the overall development and maintenance of GxP system lifecycle documentation.
40% Participate/support the planning, development, and implementation of computer systems validation documentation. Review/approve and execute computer systems validation documentation.
30% Initiate and oversee system CSV associated change control requests and associated validation documentation.
20% Facilitate, prepare and execute CSV documents for Technical Operations, QC, QA, R&D, and IT groups as necessary. Ensures schedules, and performance requirements are met
10% Provide input into the support and maintenance of CSV and IT related SOPs, work instructions, and forms. May represent CSV on specific projects, conduct briefings and technical meetings for internal and external representatives, as needed
• Possess the ability to multitask and work independently or in a team environment with moderate supervision
• Possess good interpersonal and strong written/verbal communication skills
• Well developed skills in prioritizing, organization and time management
• Highly motivated and detail oriented with good organizational skills
• Ability to work in a dynamic, fast paced environment with shifting priorities
Valid through: 6/19/2021