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Senior Validation Engineer.US-BOS.002

Posted on Sep 15, 2022 by Integra LifeSciences

Boston, MA
Research
Immediate Start
Annual Salary
Full-Time
Overview:

Integra LifeSciences is a global leader in regenerative technologies and neurosurgical solutions dedicated to limiting uncertainty for clinicians, so they can focus on providing the best patient care.



 



Founded in 1989, Integra develops, manufactures, sells and supplies best-in-class products to regenerate tissue, remove brain tumors, prevent infection and much more. And over the last three decades, we’ve evolved into one of the world’s leading global medical technology companies with more than 4,000 dedicated employees who deliver innovative medical technology solutions.



But that’s just the beginning. Integra is growing at an unprecedented rate. We’re at a moment in time where the experience you’ll gain is more robust than the experience you bring. And we’re out to invest in your future because it’s the best way to maximize ours.



 



At Integra, we firmly believe our people are our greatest asset and the foundation of our success. Our comprehensive Global Total Rewards program provides competitive compensation and benefits designed to keep our people healthy, motivated and engaged. Investing in our people through these programs is possible because of Integra’s ongoing commitment to our values and our shared success.



 



Integra’s health as a company begins with the well-being of our people. Benefit programs vary by country, whether provided through company-sponsored insurance and programs, through statutory government programs, or a combination of both.



 



Regardless of geographic location, our commitment is to offer the following, whenever possible:



Benefit plans that meet all local statutory requirements



A range of programs that reflect typical local market practices



An opportunity for employees to tailor benefits to their specific needs



Benefits that balance employee’s short-term and long-term needs



Click for more information regarding our benefits and total rewards program



Responsibilities:

Qualified candidates must possess relevant experience in one or more of the following areas of validation and be considered a Subject Matter Expert in one area:



Packaging Validation



Equipment Qualification



Process Validation



Test Method Validation



Cleaning Validation



Utility / Clean Room Validation



Temperature Mapping Studies



Statistical Sampling



 



Responsibilities associated with this position are directly associated to conducting validations related to new product introduction (NPI), product transfers, and other validation projects. The candidate must be well organized and technically sound in understanding scientific rationale and justifying acceptance criteria from a quantitative standpoint. The candidate must understand risk-based sampling. Candidate must possess sufficient knowledge and experience to serve as a subject matter expert within one area of validation. 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. An understanding of clean room practice and cGMP environments is required. 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.



Determine scope and path forward for validation requests.



Contribute to risk management activities including PFMEA generation.



Must be able to read and understand engineering P&ID’s and turnover documentation.



Scheduling coordination, material allocation and alignment of personnel in order to successfully complete validation assignments.



Mentors non-senior level validation staff.



Serve as validation representative on cross functional teams for transfer, NPI, and other projects as necessary including supervision of contract validation resources.



Experience of utility qualification, equipment qualification, process validation, packaging validation, distribution studies, aging studies.



Ensure that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements.



Ensure compliance in area of subject matter expertise across the company.



Support and address comments and suggestions associated with validation and engineering documentation.



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).



4-7 years of experience in a Validation or Quality Assurance role for a medical device or pharmaceutical environment.



Demonstrates excellent organizational and communication skills.



Results oriented with a strong focus on quality principles.



Excellent technical writing skills with an understanding of good documentation practice.



Experience conducting validation studies and managing projects independently.



Ability to track milestones and manage validation projects.



Working knowledge of applicable regulations and their interpretation within industry.



 



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.


Reference: 79314019

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