Overview
Process Validation Engineer Jobs in Austin, Texas, USA at ZipRecruiter
Job Description
Responsibilities:
Author, review, and execute validation protocols (IQ, OQ, TMV, PQ) for process validation and re-validation activities in compliance with FDA/AAMI/ISO/EN guidelines/standards.
Actively participate in all phases of process qualification.
Evaluate projects, provide guidance and technical information, generate protocols, execute qualification activities, analyze data, and prepare reports.
Lead all assigned qualification activities and make independent decisions related to these activities.
Participate in the updates of the validation plan and validation status lists.
Review qualification packages for completeness, accuracy, compliance, and sound rationale.
Compare results against acceptance criteria and collaborate with departments to resolve exceptions and deviations.
Bring critical exceptions or deviations to management’s attention and propose compliant solutions.
Lead troubleshooting activities for deviations and non-conformances.
Recommend acceptance and release of qualified systems to management.
Initiate and enforce improvements and corrections; participate in team meetings relevant to validation.
Write and review standard operating procedures detailing validation principles and activities.
Provide training and guidance to operators and technicians.
Initiate, execute, and track completion of Change Control requests.
Establish priorities and schedules to ensure timelines and milestones are met.
Participate in external audits of providers and labs.
Ensure systems run according to specifications and operate within regulations to produce quality products.
Coordinate with personnel affected by validation testing.
Compose validation execution reports and associated deviations.
Requirements:
Typically requires a minimum of 6-8 years of experience in process validation or related fields.
Knowledge of statistical tools and methodologies.
Proficiency with electronic assembly, PCB operations, testing, inspection, and mechanical/electrical tools.
Strong office skills, including data entry and proficiency with office software (word processing, spreadsheets, presentations).
Demonstrated advanced functional and technical skills, troubleshooting and diagnostic abilities.
Certification as a Quality Engineer and Six Sigma Green Belt/Black Belt.
Monitor and test equipment, analyze and document test results, and prepare compliance reports.
Direct validation activities, resolve testing problems, and adjust or improve equipment and processes.
Create databases to track validation activities and develop validation schedules.
Conduct training and oversee the work of validation technicians.
Maintain instrumentation and equipment and stay current on industry standards and regulations.
#J-18808-Ljbffr
Title: Process Validation Engineer
Company: ZipRecruiter
Location: Austin, Texas, USA
Category: Engineering (Quality Engineering), Quality Assurance – QA/QC (Quality Engineering)
