Sr.
Validation Engineer
California
Independently
provides technical validation engineering support, develops, and
creates validation protocols for major system or process modification
and capital projects.
Ensure
that all systems and equipment are validated and maintained.
Providing
validation assessments, authoring, reviewing, and approving protocols
and reports. Will provide
solutions to a variety of complex technical validation problems,
independently evaluate, select and apply standard validation
engineering techniques and procedures.
Interprets
and executes policies/procedures and leads other engineers,
contractors, and project managers on an ongoing project basis.
Routinely
audits the validation status and regulatory compliance of a number of
complex equipment or systems.
Bachelor
degree in Engineering, science or related technological field or
equivalent combination of education and experience.
Minimum of five (5)
years experience in an ISO/GMP or other regulated environment (i.e.
QSR,
OSH
, EPA) is required with
two years relevant work experience.
Working
knowledge of FDA or QSR regulation 21 CFR 820, ISO 13485 and IVDD
preferred.
Strong
analytical, presentation, and organizational skills are highly
desirable.
Demonstrate
an in-depth knowledge of validation processes and programs,
familiarity with pharmaceutical/biotech/medical devices processes and
familiarity with documentation in a highly regulated environment.
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