Senior Validation Engineer — NPI, QA & Compliance

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

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.