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Integra LifeSciences Validation Engineer in Lafayette, Indiana

Validation Engineer

US–IN–Lafayette, Vacancy ID2021-37500

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Changing lives. Building careers.

Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, reconstructive and general surgery, and regenerative wound care.

Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has more than 4,000 employees worldwide. Integra’s common stock is listed on The NASDAQ Stock Market under the symbol “IART.”

RESPONSIBILITIES

Responsibilities

Qualified candidates must be experienced in one or more of the following areas of validation:

  • Equipment Qualification

  • Process Validation

  • Cleaning validation

  • Computer System Validation

  • Test Method Validation

  • Temperature Mapping Studies

Responsibilities associated with this position are directly associated with the introduction and launching of new 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 for various utility systems, equipment and processes.

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.

Facilitate the execution of Process FMEA and other applicable risk analysis as deemed appropriate.

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

What are we looking for?

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 5 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

practice. Experience using temperature mapping equipment including Kaye Validators and Valprobes.

Competent in tracking and updating schedules to provide upper management visibility of milestones and achievements.

Ability to travel 25%.

OUR PRODUCTS

We are proud of our 25 year heritage as a leader in regenerative medicine. Today, our scientific innovation and diverse product portfolio continue to help patients and surgeons around the world.

OUR CULTURE

We have an entrepreneurial, small company feel, yet deliver big company results. Your ideas – big and small – are welcome here. We embrace change and reward our people who are committed to making Integra a stronger company.

OUR VALUES

We believe how we do things is as important as what we do. Our Values guide how we work and how we act towards our customers, patients and each other every day. We value Our People, Integrity, Excellence, Embracing Change, Decisiveness and Teamwork.

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.

This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:

EEO Is the Law (https://www.eeoc.gov/laws/index.cfm) |EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm) Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.

Please see our Privacy Policy (https://www.integralife.com/privacy) . Use of this site constitutes your consent to application of such laws and regulations and to our Privacy Policy. Your use of the information on this site is subject to our Terms of Use (https://www.integralife.com/terms) . You should view the News section and the most recent SEC Filings in the Investor section in order to receive the most current information made available by Integra Life Sciences. Contact Us (https://www.integralife.com/contact) with any questions or search this site for more information.

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