CQV Engineer

JOB DESCRIPTION:

• Candidates must have experience with authoring and executing Commissioning/Qualification protocols, including summary reports and performing root cause analysis for protocol deviations.
• The ideal candidate will have strong organization, communication, good documentation practices, technical writing, and problem-solving skills, and is driven to complete projects in a timely fashion.
• Experience working effectively as part of a cross-functional team including QA.
• Experience with leveraging commissioning for qualification (enhanced commissioning).
• Minimum 5 years of C&Q experience within a GMP-regulated environment.
• Experience with equipment utilized in Cell and Gene Therapies manufacturing and testing is preferred, but not required.

To be considered should possess the following competencies and experience outlined below, in at least one:

• Qualification of classified Cleanrooms (ISO 5, ISO 7, and ISO 8)
• Qualification of manufacturing/laboratory equipment (including 21 CFR Part 11 in addition to temperature mapping of chambers)
• Commissioning and qualification of clean utilities (compressed process air and CO2).

Experience:

• CFR Part 11: 5 years (Required)
• Cleanroom: 5 years (Required)
• commissioning for qualification: 5 years (Required)