CQV engineer
Kasmo Global
CQV Process Support Equipment Engineer
Address the work will be performed: Holly Springs NC Target start date: September 23rd OR September 30th, Onboarding happens every Monday. Length of contract assignment: 10 months Work schedule: There are shifts here that are not defined yet. Hiring manager is in the late stages of determining whether there will be 2 or 3 shifts. There are going to be weekend shifts with this role. This role will have an overnight shift. They are asking for candidates to be open-minded.
Client description: Our client is a leader in the CDMO realm whose focus is to combine technical leadership in cell culture, microbial fermentation, and cell and gene therapy with world class GMP facilities to advance tomorrow's medicines.
Opportunity to work for one of the leaders in the biotechnology industry with a focus on supporting their customers with the development and manufacturing of recombinant proteins, viral vaccines, and gene therapies. Strong leadership team. Continued investment into the development of the business as they recently just acquired $1.2 billion in funding to expand their manufacturing facilities.
Project description: Our client is in need of bringing on additional CQV Process Support Equipment Engineers to support an uptick in expected workload. This individual will be joining an existing CQV department of 120 individuals and will be reporting into the manager of CQV who oversees the following workstreams: CIP, CTU, Cleaning and Process Support Equipment.
Consultants day to day responsibilities:
- The ideal individual will be a part of the process support equipment team and will be working with the following equipment on a daily basis: Parts washers, bio safety cabinets, laminate flow hoods, isolators, scales, autoclaves, tube welders, sealers
- Individual will be working extensively with parts washers and autoclaves are the more complex equipment
- Will be responsible for starting up, commissioning and the qualification of washers
- Qualified individual will be experienced working in Kneat for validation, commissioning and qualification documents
- This individual will be leaned on as a SME in parts washers and autoclaves
Required Skills:
- 5+ years of experience in a GMP CQV process support equipment role
- Engineering background
- Kneat /ValGenesis or similar validation software experience
- Needs to have hands on experience and in-depth technical understanding of process support equipment o Parts washers, bio safety cabinets, laminate flow hoods, isolators, scales, autoclaves, tube welders, sealers
- Prior hands-on experience in the startup for commissioning qualification of Getinge parts washers
Vacancy posted 2 days ago
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