Validation Engineer - Los Angeles, United States - United Consulting Hub

Description

Title:
Validation Engineer


Location:
California (Onsite)

Duration: 12 Months

On W2 only

Injectable Filler / IV Bags Filling

experience must.
Aseptic Processing

is must.
knowledge of

validation lifecycles for computerized systems (CSV), aseptic processing, sterilization validation, and equipment/facility/utility validation .
GMP compliance

knowledge
Positions will report to the Validation Team management, who will instruct candidate on project scope and priorities. Positions will require someone who can work with several teams and lead the process.
Previous experience with

mechanical validation, computer system validation (CSV), change control, CAPAs/deviations, data integrity,

and project management required.
Support the

Validation Manager by ensuring effective implementation and maintenance of the Validation

program.
Responsible for the writing of and the execution of project and

system qualifications, validation, and Re- qualification/periodic

reviews.

Develops validation plans, qualification protocols, compiles and analyzes data, drafts summary reports, and reviews validation documentation to ensure that system are qualified in accordance with applicable regulatory agencies, clients and Lonza specifications/requirements.

Assures that all

validation documentation meets or exceeds the regulatory expectations .

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