Engineer II, Quality Validation
Engineer II, Quality Validation
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Job Description
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 whats possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.
SUMMARY
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.
ESSENTIAL DUTIES AND RESPONSIBILITIES
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.
DESIRED MINIMUM QUALIFICATIONS
The requirements listed below are representative of the knowledge skill and/or ability required for this position.
Bachelor degree or equivalent with 3 years of experience Master degree with 0-2 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.
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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EEO Is the Law EOE including Disability/Protected Veterans
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. If you have difficulty using our online system due to a disability and need an accommodation please email us at
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Employment Type
Full-Time
