Validation Engineer II

Responsibilities

Responsibilities associated with this position are directly associated with the introduction and launching of new equipment or products and processes into a manufacturing facility.

• Generation and execution of qualification/validation protocols including the generation, routing and approval of summary documentation.
• Must be able to read and understand engineering P&AID's and turnover documentation.
• Work with project teams to develop DOEs and statistically sound tests for appropriate support of results.
• Complete test method validation, gauge r&r studies and other qualifications or studies to support product testing.
• Scheduling coordination, material allocation and alignment of personnel in order to successfully complete validation assignments.
• Develop statistically based sampling plans for in-process and final test sequencing.
• Ensure that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements.
• Support and address comments and suggestions associated with validation and engineering documentation.
• Protocol, Deviation, and summary report generation and approval.
• Change control, non-conformance and CAPA support.
• Participate in FDA inspections, ISO certifications, surveillance audits and customer audits.

• Bachelors Degree in Engineering (Biomedical, mechanical, chemical, or electrical) or Science (Biology, Chemistry).
• 2 to 6 years of experience in a Validation or Quality Assurance role for a medical device or pharmaceutical environment.
• Demonstrates excellent organizational and communication skills.
• Experience with qualifying medical device manufacturing equipment.
• Results oriented with a strong focus on quality principles and conflict resolution.
• Excellent technical writing skills with a thorough understanding of good documentation practices.
• Experience using temperature mapping equipment including Kaye Validators and Valprobes preferred.
• Competent in tracking and updating schedules to provide upper management visibility of milestones and achievements.

$71,300.00 - $97,750.00 USD Salary

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, Employees are eligible for the following:

Integra Life Sciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.
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