Commissioning & Qualification (CQV) Engineering Consultant - Southeast
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About The Position
Sequence, Inc. is seeking CQV Consultants to join our Southeast Operations, primarily focusing on projects within the pharmaceutical and biotechnology sectors. In this role, you will be engaged in a variety of tasks related to the commissioning and qualification of automated manufacturing systems, which include laboratory instrumentation, manufacturing equipment, and stand-alone computerized systems. You will also have the opportunity to participate in Pharma 4.0™ transformations and implementations, which are at the forefront of the industry. As a CQV Consultant, you will be responsible for managing specific project deliverables on a day-to-day basis. This includes the creation and modification of essential design documentation such as User Requirements Specifications (URS), Functional Requirement Specifications (FRS), and detailed design documentation. You will also participate in system classification, risk assessments, and vendor assessments, ensuring that all documentation meets the necessary regulatory standards. Your role will involve drafting and executing commissioning and qualification protocols, conducting performance qualifications, and supporting ongoing system requalification and continuous improvement activities governed by change management processes. This position requires a willingness to travel, as you may need to temporarily relocate to project sites both domestically and internationally, depending on project demands. Travel for client meetings or project deliverables may also be required, typically ranging from 10% to 30% of your working time. The extent of travel will be project-specific and communicated in advance. We are looking for individuals who embody Sequence's core values of selfless attitude, aptitude for continued learning, and unstoppable initiative. If you are passionate about engineering and eager to contribute to high-quality deliverables in the pharmaceutical and biotech industries, we encourage you to apply and join our rapidly growing consulting firm.
