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.

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 introductions (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.

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.

• Determine scope and path forward for validation requests.

• 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.

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

• Ensure compliance in areas of subject matter expertise across the company.

• 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.

QUALIFICATONS:

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

• Bachelor's degree in engineering (Biomedical, mechanical, chemical, or electrical) or Science (Biology, Chemistry).

• 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.

• Experience conducting validation studies and managing projects independently.

• 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.

• Working knowledge of applicable regulations and their interpretation within industry.

• Ability to travel 10%.

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 (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.

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