Engineer Ii, Quality Validation

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.

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:

• Process Validation
• Packaging Validation
• Cleaning Validation
• Test Method Validation
• Temperature Mapping Studies
• Utility / Clean Room Validation
• Statistical Sampling
• Equipment Qualification

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:

• Applies knowledge of job discipline's best practices to internal processes
• Specialized knowledge level, seasoned professional with complete and in-depth conceptual and practical knowledge in one or many areas of Quality Validation
• Serve as validation representative on cross functional teams for transfer, NPI, and other projects as necessary including supervision of contract validation resources.
• Practical knowledge of project management
• Support and address comments and suggestions associated with validation and engineering documentation.
• Experience of utility qualification, equipment qualification, process validation, packaging validation, distribution studies, aging studies.
• Generation and execution of qualification/validation protocols including the generation, routing and approval of summary documentation.
• Positions at this level are individual contributors and team members
• Participate in FDA inspections, ISO certifications, surveillance audits and customer audits.
• Change control, non-conformance and CAPA support.
• Contribute to risk management activities including PFMEA generation.
• Mentors non-senior level validation staff.
• Determine scope and path forward for validation requests.
• Ensure compliance in area of subject matter expertise across the company.
• 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.
• Ensure that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements.

Qualifications:

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

• Excellent technical writing skills with an understanding of good documentation practice.
• Experience conducting validation studies and managing projects independently.
• Working knowledge of applicable regulations and their interpretation within industry.
• Demonstrates excellent organizational and communication skills.
• Ability to track milestones and manage validation projects.
• 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
• Results oriented with a strong focus on quality principles.
• 3-4 years of experience in a Validation or Quality Assurance role for a medical device or pharmaceutical environment.
• Bachelor's Degree in Engineering (Biomedical, mechanical, chemical, or electrical) or Science (Biology, Chemistry)

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: $77,367.91 - $93,174.25 per year

Benefits:

• Health insurance
• Dental insurance
• Referral program
• 401(k)
• 401(k) matching
• Health savings account
• Vision insurance
• Paid time off

Experience level:

• 5 years

Schedule:

• 8 hour shift

Work setting:

• In-person

Work Location: One location