Senior Validation Engineer – NPI, Transfer & CAPA Leadership

TEI BIOSCIENCES INC; Braintree (MA); On-site; USD 94,300 - 129,950; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) Savings plan

Life insurance

Job summary

TEI BIOSCIENCES INC is seeking a qualified Validation Subject Matter Expert based in Braintree, Massachusetts. This role requires strong experience in validation processes and risk management within a cGMP environment. Key responsibilities include executing validation protocols, mentoring staff, and ensuring compliance with FDA standards.

Candidates should possess a Bachelor's degree in Engineering or Science, with at least 8 years of relevant experience. The position offers a competitive salary and comprehensive benefits, including medical and dental insurance.

Qualifications

• Bachelor's degree required with relevant experience.
• Experience in Validation or Quality Assurance for medical devices.
• Strong organizational and communication skills.

Responsibilities

• Generate and execute qualification/validation protocols.
• Mentor non-senior level validation staff.
• Participate in FDA inspections and audits.

Skills

Validation expertise

Clean room practice

Risk management

Technical writing

Education

Bachelor's degree in Engineering or Science

Master's degree with 5 years experience

Job description

TEI BIOSCIENCES INC is seeking a qualified Validation Subject Matter Expert based in Braintree, Massachusetts. This role requires strong experience in validation processes and risk management within a cGMP environment. Key responsibilities include executing validation protocols, mentoring staff, and ensuring compliance with FDA standards.

Candidates should possess a Bachelor's degree in Engineering or Science, with at least 8 years of relevant experience. The position offers a competitive salary and comprehensive benefits, including medical and dental insurance.