Verification Support Engineer

Roles & Responsibilities Pharmacy Verification Support engineer for a minimum of years. Working knowledge of software or system validation in regulated industry like Medical Device or Pharma. Strong knowledge and experience of computerized system development life cycle (SDLC) approaches and validations strategies is required. Experience with COTS/Custom made Analytical Instrument and experience working in QC Laboratories, R&D, manufacturing/operations is required. Software Quality Engineer (SQE)/ Computer System Validation (CSV) experience in Pharma/Medical Device is required. Good knowledge of the areas of GxP is required including knowledge of CSV and data integrity regulations including but not limited to CFR Part . Experience in LIMS/CDS/ Analytical Instrumentation Validation is preferred and not mandatory. Familiar or Experience in Quality Systems process development, support, integration, or enhancement is preferred. Software Quality Engineer certification (CSQE) or Certified Quality Engineer certification (CQE) is preferred not mandatory. Strong knowledge and experience of computerized system development life cycle approaches and validations strategies is required. Familiarity with bioanalytical work and workflows, instrument software, and computer systems validation in the bioanalytical space is preferred. Excellent communication, social skills, networking skills, a high level of organizational ability, and attention to detail is required. Good interpersonal skills and Communication with the system administrator, system owner, and lab manager to plan, coordinate, implement and validation. Working knowledge of GAMP and SDLC is preferred A minimum of years of experience in a regulated environment is required. #J-18808-Ljbffr Katalyst HealthCares & Life Sciences