Integra LifeSciences · 5 months ago
Validation Engineer II
US-NJ-Plainsboro-105-Facility
Full-time
Onsite
Entry, Mid Level
2+ years expIntegra LifeSciences is a company focused on creating change and shaping the future of healthcare. They are seeking a Validation Engineer II to manage the introduction and launching of new equipment or products into a manufacturing facility, ensuring compliance with regulatory requirements and supporting validation processes.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
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&ID’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
Qualification
Required
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
Competent in tracking and updating schedules to provide upper management visibility of milestones and achievements
Preferred
Experience using temperature mapping equipment including Kaye Validators and Valprobes
Company
Integra LifeSciences
Integra LifeSciences is an integrated medical device company.
1001-5000 employees
H1B Sponsorship
Integra LifeSciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (5)
2023 (4)
2022 (7)
2021 (5)
2020 (4)
Funding
Current Stage
Public CompanyTotal Funding
$350M2018-05-15Post Ipo Equity· $350M
1995-08-25IPO
Leadership Team
Mojdeh Poul
Chief Executive Officer
Lea Knight
EVP and Chief Financial Officer
Recent News
Integra LifeSciences Holdings Corporation
2025-12-02
Company data provided by crunchbase