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13 days old

CQV Engineer

Kelly Services
Morrisville, NC 27560
**Kelly Engineering** is currently recruiting for a **1 Year Contract with Benefits!, Quality Assurance CQV SME** job located in **Morrisville, NC.** We are currently seeking a Quality Assurance CQV SME to join us as we build the largest life science and CDMO facility in the US. This SME role will be a key QA partner for CQV Engineering to assure CQV quality and cGMP compliance for the new Drug Product and Finished Goods manufacturing facility and will report to the site QA CQV Lead. The successful candidate will be able to partner prospectively with CQV Engineering to create efficient and cGMP compliant CQV plans and documents for facilities, utilities, and equipment utilized in Drug Product formulation, sterile filling, and packaging processes. This role provides critical quality assurance oversight for all CQV related documentation and quality assurance partnership for detailed designs for the Drug Product Finished Goods facility.


**Job Responsibilities:**


+ Provide quality assurance partnership with CQV engineers tasked with establishing an efficient and cGMP compliant CQV process for the project

+ Leverage existing CQV processes, procedures, and documents from other facilities, where possible, to provide efficient, agile, and aligned QA CQV Plan for the project to cover all aspects from conceptual design through to beginning of plant operations

+ Assure suitability and cGMP compliance through approvals of FAT, SAT, Commissioning, IQ, OQ and PQ as well as Validation Final Reports, Validation Project Plans, Cleaning Validation documents, Risk Assessments, Traceability Matrices, etc.

+ Contribute, as necessary, to QA supplier qualification, audit and approval process as well as operations to support the project

+ Provide quality assurance support for detailed design activities for the Drug Product Finished Goods Facility

+ Create and maintain reliable concise planning and tracking of assigned responsibilities and functions


**Basic Requirements:**


+ Bring contagious positive enthusiasm and an agile proactive mindset to quality and cGMP compliance

+ Minimum of 8 years CQV Biotech experience on Large Scale Projects with desired experience with Drug Product formulation, sterile filling, and packaging CQV and facility detailed designs

+ Have current knowledge of Biotech Drug Product formulation, sterile filling, and packaging cGMP requirements for the CQV of facilities, utilities, and equipment including cleaning validation and a working knowledge of ASTM E2500 / Leveraging Verification process

+ Capable of partnering to assure suitability and cGMP compliance of FAT, SAT, Commissioning, IQ, OQ and PQ as well as Validation Final Reports, Validation Project Plan, Annual Validation documents etc.

+ Have knowledge of multi product CDMO facilities and their operation, preferably with experience in ADE/PDE and cleaning validation

+ Have excellent communication / presentation skills, and be able to articulate complex information to stakeholders and supporting functions such as CQV, QC, Engineering, Automation and Senior Management

+ Experience with complex projects and the ability to keep work pace and meet deadlines with good organization and planning skills


\#TJP2021_SPEC


**Why Kelly** **** **?**


Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, were here every step of the way to find your dream engineering job.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
Posted: 2021-10-04 Expires: 2021-11-04

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CQV Engineer

Kelly Services
Morrisville, NC 27560

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