Validation Engineer II

Integra LifeSciences is a global medical technology leader in neurosurgery and regenerative medicine driven by our purpose of restoring patients’ lives. The company offers a broad portfolio of products and innovative solutions for dural access and repair, cerebral spinal fluid management and neuro-critical care. Its regenerative tissue technologies include products that address soft tissue, peripheral nerve and tendon repairs and for the treatment of acute and chronic wounds, burns, as well as for plastic and reconstructive surgery.

Founded in 1989 by Richard E. Caruso, the company is headquartered in Princeton, New Jersey. Today, Integra LifeSciences has grown immensely, with more than 4200 employees worldwide as well as offices, manufacturing and research facilities in Asia, Australia, Europe, Middle East, and the Americas.

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.

Responsibilities associated with this position are directly associated with the introduction and launching of new equipment or products and processes into a manufacturing facility. The candidate must utilize problem solving techniques to resolve issues and conflict in order to meet the high level goals set forth by the organization. The candidate must be well organized and technically sound in understanding scientific rationale and justifying criterion from a quantitative standpoint. The candidate must be familiar with process flow of a medical device organization, including the regulatory impact of change and the documentation path of a compliant process. The candidate must possess technical writing experience in protocol generation and procedure generation. Some experience is required in master plan generation and the change control life cycle. The candidate must be a team player who thrives in a team environment, but also has the capability to work on their own to research and investigate. Gown qualification is a plus, with an understanding of clean room practice and cGMP environments. The qualified candidate must understand the concepts of risk management and the ability to identify and classify critical parameters within a production setting.

To perform this job successfully, an individual must be able to perform each essential duty

Satisfactorily:

• 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.

QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

• 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.

Integra LifeSciences 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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