Manager, Process Validation

Organization
Pacific Biosciences
Job Location
1380 Willow Road
Menlo Park, CA 94025
Job Description

Pacific Biosciences is looking for a candidate to lead the Process Validation activities.  He/she will be responsible for developing related processes and methodologies.  The candidate will work closely with the R&D and Manufacturing staff to ensure process validation requirements are met.

 Responsibilities:         
•    Manage the development and execution of the process validation activities.
•    Develop and implement strategies for equipment IQ/OQ/PQ, test method validation, and spreadsheet validation.
•    Ensure the validation program meets requirements for in vitro diagnostics products.
•    Perform risk assessments in conjunction with Quality and Operations subject matter experts.
•    Provide updates to the Management team on process validation activities.
•    Provide training to staff involved with the process validation activities.

Requirements

•    Bachelors, or Masters in a related field with a minimum of 10 years of process validation experience in an FDA-regulated environment (preferably IVD).
•    Ability to lead a team of validation engineers and manage multiple projects.
•    Demonstrated history of working in a fast pace cross-functional environment.
•    Expert knowledge of Validation principles and Risk Analysis.  Expert knowledge of FDA 21 CFR Part 11/820, ISO 13485, ISO 14971, GAMP 5.
•    Solid understanding of reagent manufacturing processes.
•    Strong analytical problem solving experience.  Hands on experience with statistics, and Statistical Process Control.
•    Excellent verbal and written communication/documentation skills.

All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, protected veteran status, or on the basis of disability, gender identity, and sexual orientation.

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