Changing lives. Building Careers.
Joining us is a chance for you 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, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.
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:
- Requires a basic understanding and application of discipline – including the underlying principles involved, as opposed to practices.
- Positions at this level are individual contributors and team members
- Works to achieve assigned operational targets with direct impact on team results
- Receives moderate instruction and guidance to achieve objectives
- 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&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:
The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.
- Minimum required education and experience: Bachelor degree or equivalent with 3+ years of experience, Master degree with 0-2 years of experience
- Bachelors Degree in Engineering (Biomedical, mechanical, chemical, or electrical) or Science (Biology, Chemistry)
- 1-3 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.
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
Job Type: Full-time
Pay: $80,699.31 - $97,186.27 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Health savings account
- Paid time off
- Referral program
- Vision insurance
Experience level:
Schedule:
Work setting:
Work Location: One location
