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.