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Validation Engineer

  • Permanent
  • Anywhere

Website Integra LifeSciences

Integra LifeSciences

Company : Integra LifeSciences

Country: United States

Location : Boston, Massachusetts

Post: Thu, 23 Sep 2021 06:16:44 GMT

Expires: Sat, 23 Oct 2021 23:59:59 GMT

Apply Job : Apply Online

—————————— Job Description ——————————

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.

Must be able to read and understand engineering P&IDs 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.

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%.

IN AN EFFORT TO MINIMIZE THE SPREAD OF THE CORONAVIRUS AND TO PROTECT OUR EMPLOYEES, ALL NEW HIRES IN THE US AND PUERTO RICO WILL NEED TO BE FULLY VACCINATED FOR COVID-19 IN ORDER TO BE CONSIDERED FOR EMPLOYMENT WITH INTEGRA LIFESCIENCES, UNLESS ELIGIBLE FOR AN ACCOMMODATION AS PROVIDED BY LAW.

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