CSV Engineer III
Piper Life Sciences is currently seeking a CSV Engineer III in the area of Frederick County, MD. The CSV Engineer III will be supporting as a consultant for leading pharmaceutical, medical device, and biotechnology manufacturers.
Responsibilities for the CSV Engineer III:
- Ability to plan and execute functional and performance testing associated with existing development and infrastructure projects
- Identifying software problems and their causes through the design, development, implementation, and execution of test plans and test scripts
- Testing version/change control and new software rollouts (SDLC)
- Ensure that testing meeting all regulatory requirements (21CFR Part 11, ISO 13485, ISO 14971)
- Additional duties as assigned
Qualifications for the CSV Engineer III:
- 4 (four) to 9 (nine) years of experience in a regulated manufacturing environment (biotechnology, pharmaceutical, or medical device industry required)
- Experience with Validation (IQ, OQ, PQ, PV, CV, CSV), Quality Systems (chance control, requalification), design documentation (URS, FS, DS)
- Must be willing to travel
- Bachelor's Degree in Engineering, Science or related technical field (Master's preferred)
Compensation for the CSV Engineer III:
- Salary range: $80,000 - $130,000 (commensurate with years of experience)
- Benefits include: Health, Dental & Vision Insurance, 401k
Keywords:
CSV Engineer, Computer Systems Validation, CSV, consulting, drug discovery, GxP, IQ, OQ, PQ, pharmaceutical, biotechnology, medical device, manufacturing, functional testing, software, infrastructure projects, SDLC, version control, change control, Software Project Development Life Cycle, analysis, design, testing, software application, regulatory requirements, 21 CFR Part 11, ISO 13485, ISO 14971, technical degree, Engineering, Science, Life Science, URS, FS, PV, CV, non-conformances, requalification, Six-Signma, Lean, MS, MA, BS, BA