Company : Katalyst Healthcares & Life Sciences
Country: United States
Location : Gaithersburg, Maryland
Post: Sun, 29 Oct 2023 06:31:17 GMT
Expires: Sun, 26 Nov 2023 23:59:59 GMT
Apply Job : Apply Online
—————————— Job Description ——————————
Roles & Responsibilities:
Leads and provides validation support to multiple projects.
Acts as technical owner of specific area within validation function or as deep specialist in one validation field.
Works on validation project planning by reporting on project schedules and work
Deep technical knowledge of Validation of equipment, facilities, and utilities
Ensures validation program meets corporate and regulatory expectations.
Crafts and updates Validation master plans.
Evaluates contractors for execution of validation work.
Strong risk assessment understanding and experience writing those assessments.
Leads installation activities to ensure validations standards are met.
Write and performs Equipment, Facility and Process Installation/Operational/Performance Qualifications (IQ/OQ/PQ).
Writes deviations, root causes, corrective actions, and additional testing.
Education & Experience:
Bachelor’s degree in science is required.
Minimum 7 Years Experience In Validation
Equipment, Utilities And Facilities Validation Experience Required.
PMP experience is a plus.
Biotechnology manufacturing experience is a plus.
Annex 1 experience is a plus.