Hologic San Diego CA United States
1 month ago
Our Quality Engineering team is looking to hire a Validation Engineer 2 (Quality Engineer) responsible for the validation of analytical methods, cleaning, production process, equipment qualification, facilities/utilities qualification, and raw materials qualification.
Additionally, this person will generage and maintain process FMEA for production processes, perform risk assessments for... process-related non-conformances and planned deviations, provide support and content for regulatory submissions, write master validation plans, protocols and reports, support equipment and facilities change controls, and perform validation impact assessment for change orders.
Essential Duties and Responsibilities
Author master validation plans and reports
Author and execute validation protocols and reports for Analytical Methods, Equipment, Facilities/Utilities, Raw Materials, Process, and Cleaning
Review the quality, validation impact, and completeness of document change order requests and change controls
Determine validation strategy based on acceptable risk-based approach
Lead cross-functional team to write FMEAs under limited supervision
Perform process risk assessment for Non-Conformance Events (NCEs) and planned deviations (PDV)
Assist in maintaining validation records
Review regulatory submissions and/or notifications under limited supervision
Propose improvement projects with supporting data, flowcharts, etc.
Assist in developing/updating departmental procedures and other controlled documents
Evaluate adequacy of specifications for new or modified process designs under limited supervision
Lead department and cross-department projects under limited supervision. Determine QE deliverables and assist in generating project timelines
Participate in process design reviews
Assist QE management in Material Review Board (MRB) and Production Response Team (PRT) meetings
Participate in department process improvements goal(s)
Proficient in validation methods and evaluation criteria
Experience with 2+ of the following: process validation, analytical method validation, cleaning validation, facility/utility and equipment qualifications
Experience with change control process and documentation requirements
Experience with electronic document management systems
Understanding of statistics, SPC and acceptance sampling
Experience with risk analysis and FMEA
Working knowledge of CDRH, CBER and ISO regulations (e.g., 21 CFR Part 820, ISO 13485, ISO 14971)
Working knowledge of 21 CFR Part 11
Bachelor’s degree in Science or Engineering.
2-5 years of experience in a diagnostic, medical device, biotech or pharmaceutical company
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Agency And Third Party Recruiter Notice
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
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