Senior Engineer II, Quality Validation

Integra LifeSciences; Braintree (MA); On-site; USD 94,300 - 129,950; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) savings plan

Job summary

Integra LifeSciences seeks a Validation Specialist in Braintree, Massachusetts to support validations for new product introductions and enhancement projects. Candidates should possess a Bachelor's degree in Engineering or Science and substantial experience in validation within a medical device or pharmaceutical environment.

Responsibilities encompass mentorship to validation staff and ensuring compliance with industry standards including cGMP and ISO. Benefits include comprehensive health insurance and a 401(k) plan.

Qualifications

• 8+ years of experience with Bachelor's, 5+ years with Master's, or 3+ years with Doctorate.
• 1-3 years in Validation or Quality Assurance for medical devices or pharmaceuticals.
• Proficiency in applicable regulations and their interpretation.

Responsibilities

• Support validations related to new product introductions and transfers.
• Contribute to risk management activities including PFMEA generation.
• Ensure compliance with cGMP, cGLP, ISO, and other applicable requirements.

Skills

Organizational skills

Technical writing

Project management

Quality principles

Education

Bachelor's Degree in Engineering or Science

Job description

Responsibilities

Reviewed and supported validations related to new product introduction (NPI), product transfers, and other validation projects. The candidate must be well‑organized, technically sound in understanding scientific rationale, and capable of justifying acceptance criteria from a quantitative standpoint, including risk‑based sampling.

• Mentors non‑senior level validation staff.
• 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 to successfully complete validation assignments.
• 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

• Minimum required education and experience: Bachelor's degree or equivalent with 8 years of experience; Master's degree with 5 years of experience; Doctoral degree with 3 years of experience.
• Bachelor's Degree in Engineering (Biomedical, mechanical, chemical, or electrical) or Science (Biology, Chemistry) or a closely related technical discipline is required.
• 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.

Salary & Benefits

Salary Pay Range: $94,300.00 - $129,950.00 USD Salary.

Benefits include: medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, group legal insurance, and 401(k) savings plan.

Equal Employment Opportunity

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.

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 [e-mail].