Validation Engineer II - MSAT
Company: Planet Pharma
Posted on: August 2, 2022
Provide Commissioning and Qualification (C&Q) Support to
Vacaville Manufacturing operations for project delivery and
operational support, focused on the Qualification Lifecycle
Document Remediation project.
- 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 procedures and approved
- 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 job experience.
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 industry trends.
- 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
- Need to be able to lift 50 lb or greater and work in a clean
room environment for long periods of time.
The Planet Group of Companies is an equal opportunity employer. We
celebrate diversity and are committed to creating an inclusive
environment for all employees.
Keywords: Planet Pharma, Vacaville , Validation Engineer II - MSAT, Engineering , Vacaville, California
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