Process Validation Engineer

Responsibilities:

• Defines validation strategy and requirements and ensure implementation.
• Review and approve validation requirements, master validation plan/report, validation protocols/ reports to support Process Validation and re-validation activities for New Product Introduction and Sustaining in accordance with FDA/AAMI/ISO/EN guidelines/standards.
• Actively participate during all phases of process qualification.
• Evaluate projects, provides guidance and technical information to others to generate protocols, execute qualification activities, analyze resulting data and to prepare reports.
• Lead and assist in all assigned qualification activities.
• Determine and establish requirements for qualification activities.
• Make independent decisions related to qualification activities.
• Participate in the generation and/or update of the validation plan and validation status lists.
• Review qualification packages for completeness and accuracy, sound rationale, compliance with validation policies and procedures, and accurate data analysis.
• Compare results against acceptance criteria and work with appropriate departments to resolve exceptions and deviations.
• Bring critical exceptions or deviations to management's attention and propose compliant solutions.

Requirements:

• Lead trouble shooting activities for deviations and non-conformances.
• Recommend to management as to the acceptance and release of qualified systems.
• Initiate and enforce necessary improvements and corrections; attend team meetings pertinent to validation.
• Write and revise standard operating procedures describing validation principles and activities.
• Provide training and guidance to applicable operators and technicians
• Initiate, execute, and track completion of Change Control requests.
• Establish priorities and schedule activities to ensure timelines and milestones are met.
• Participate in external audits of providers and labs.
• Ensure all systems are running according to necessary specifications and operate within regulations to ensure the production of quality products.
• Responsible for establishing validation standards.
• Coordinate with required personnel affected by validation testing.
• Review and approve validation execution reports, and associated deviations.
• Analyzes test results.
• Reviews and prepares compliance reports.
• Directs validation activities.
• Resolves testing problems.
• Makes adjustments or improvements to equipment and processes.
• Creates databases to track validation activities.
• Interprets customer requirements.
• Develops validation schedules.
• Conducts training and overseeing the work of validation technicians.
• Keeps up to date on industry standards and regulations.

Job Type: Contract

Experience level:

• 4 years

Schedule:

• Day shift

Ability to Relocate:

• Austin, TX: Relocate before starting work (Required)

Work Location: In person