US_Validation Engineer II_22094_Qualification Lifecycle Document Remediation Project #: 22-06406
Company: HireTalent - Diversity Staffing & Recruiting Firm
Posted on: August 2, 2022
Job Title: Validation Engineer II
Job Location: Vacaville, CA
Job Duration: 24+ Months (W2)
Provide Commissioning and Qualification (C&Q) Support to
Vacaville Manufacturing operations for
project delivery and operational support, focused on the
Qualification Lifecycle Document Remediation
- Completion of all applicable training requirements required to
support project activities
- Work with cross-functional teams to support development of
Qualification Plan and Summary
- Support in the development of design and risk assessment
- Leverage risk management principles to drive risk-based
validation testing and decision-making.
- Development, approval, and execution of qualification
deliverables for the completion of
Commissioning & Qualification (C&Q) activities in accordance
with Genentech procedures and
approved Qualification strategy
- Support development and execution of planned and unplanned
- Review, and revise Qualification Lifecycle documents
- Bachelor's degree (Life Science, Engineering, Biology,
Biochemistry) or equivalent validation/GMP
Experience (may vary depending on site size/scope)
- Four or more years of validation experience (or equivalent
experience) in a cGMP environment for a
wide range of validation projects including validation of
large-scale biochemical manufacturing
equipment, utility and facility systems.
- Has advanced knowledge of validation principles, manufacturing
processes, quality systems,
engineering design fundamentals, regulatory agency expectations and
- Strong technical writing, verbal communication, interpersonal
and problem-solving skills.
- Ability to work independently, organize and manage individual
as well as larger scale projects.
Work Environment/Physical Demands/Safety Considerations
- Vigilant to safety and maintains a safe environment for all
during performance of job responsibilities
(i.e. Validation Field Execution).
- Need to be able to lift 50 lb or greater and work in a clean
room environment for long periods of time.
Job descriptions are not intended, and should not be construed, to
be all-inclusive lists of all responsibilities,
skills, efforts, or working conditions associated with a job. While
this description is intended to be an
accurate reflection of the job requirements, management reserves
the right to modify, add, or remove duties
and to assign other duties as necessary.
Keywords: HireTalent - Diversity Staffing & Recruiting Firm, Vacaville , US_Validation Engineer II_22094_Qualification Lifecycle Document Remediation Project #: 22-06406, Engineering , Vacaville, California
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