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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:
- Specialized knowledge level, seasoned professional with complete and in-depth conceptual and practical knowledge in one or many areas of Quality Validation
- Applies knowledge of job discipline's best practices to internal processes
- Practical knowledge of project management
- Positions at this level are individual contributors and team members
- 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.
- Minimum required education and experience: Bachelor's degree or equivalent with 5+ years of experience, Master degree with 3+ years of experience, Doctoral degree with 0-2 years of experience
- Bachelor's Degree in Engineering (Biomedical, mechanical, chemical, or electrical) or Science (Biology, Chemistry)
- 3-4 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.
This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:
EEO Is the Law| EOE including Disability/Protected Veterans
Job Type: Full-time
Pay: $77,367.91 - $93,174.25 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
