CSV Engineer

Found in: beBee jobs US - 2 weeks ago

East Case, United States Katalyst Healthcares & Life Sciences Full time

Responsibilities:
Ability to mentor and guide less experienced team members.

Independently understanding client's quality standards, cGMP's, and regulatory standards to support team in compliance of validation effort.

Independent verification of testing against specifications.


Managing and working collaboratively with clients' quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities.

Includes ability to complete root cause analysis.


Supporting clients change management program including authoring proposed changes, executing impact assessments/ regression analysis, and supporting client documentation of change results and release.

Hands on experience with lab techniques and general lab analytical operations.

Understanding of baselined lab standards and system suitability verification

Familiarity with bench top analytical equipment and have worked with chromatography and LIMS system sample workflows.

Direct experience with system design and/or configuration activities.