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Process Quality Engineer - Biochemical Manufacturing
Process Quality role which supports the entire product lifecycle.
Waltham-based company which has been praised for organic growth.
About Our Client
Our client is a bioprocessing-focused life sciences company bringing over 30 years innovation to its customers. This manufacturer drives bioprocessing through the development and commercialization of high-value products and flexible solutions that address critical steps in the production of biologic drugs, principally monoclonal antibodies.
The successful candidate will be responsible to provide Process/Quality Engineering support to manufacturing helping to ensure delivery of highest quality product to the customer. Provide direction in the areas of Design Controls & Risk Management to cross-functional teams responsible for new product development or design changes. Support the review and release of the new product line.
The Successful Applicant
- At a minimum, a BA/BS degree in a technical discipline is required!
- At least one year of Design Quality experience in a life sciences or medical device industry
- Must have direct experience with customers
- Understanding of basic chromatography, fermentation and purification (production and lab scale) is required for this position
- Minimum 3-7 years' experience in Quality or Process Engineering in an ISO 9001 or ISO13485 certified Quality Management System or equivalent
What's on Offer
- Strong base salary
- Work with products which save lives
- Excellent benefits package
- This company offers organic growth and a clear growth track - this position is open due to a promotion!
- Great exposure to engineering throughout the product life-cycle