MD: CAPA/Process Engineer (3 spots) (232137)

Life Sciences & Technology
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Job Description 

Our client is looking for several Deviations Writers to come in and assist with the backlog of deviations they need done by mid- February the latest. They will be needed for the operations piece for deviation support, they already have a team of QA folks to support the closure of the deviations so they will be needed primarily for manufacturing operations deviations.

Required Skill

Strong biologics experience
Strong understanding of unit operations – cell culture, bioreactor, TFF, Chromatography, filtrations, etc.
Strong knowledge of Single use disposable systems
Preferred experience in manufacturing but quality and/or validation setting experience is acceptable as long as unit ops familiarity exists
Proven experience with authoring, reviewing, approving deviations/non-conformances
Trained with understanding of RCA techniques – 5Whys, 6Ms, fishbone, etc.
Have worked with batch records and have familiarity with workings of cGMP mfg environment
Life science or engineering degree with at least 5+ yrs of direct relevant exp.
Use of TrackWise system or similar operating framework
Strong writing skills is a must

MD: CAPA/Process Engineer (3 spots) (232137)

About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
ASAP
Location
Mid-Atlantic

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