Validation Engineer II

Changing lives. Building Careers.

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

• 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&'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 to successfully complete validation assignments.
• Develop statistically based sampling plans for in-process and final test sequencing.
• Ensure 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.

• Bachelor’s 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.

Salary Pay Range: $71,300.00 - $97,750.00 USD Salary

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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