Senior Engineer II, Quality Validation

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

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 related to review and support 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. They must understand risk-based sampling, risk management, and the ability to identify and classify critical parameters within a production setting.

An understanding of clean room practice and cGMP environments is required. The candidate must be a team player who thrives in a team environment but also can work independently to research and investigate. They must be able to read and understand engineering P&ID’s and turnover documentation.

Key duties include:

• Generation and execution of qualification/validation protocols, including routing and approval of summary documentation.
• Determining scope and path forward for validation requests.
• Contributing to risk management activities including PFMEA generation.
• Scheduling coordination, material allocation, and alignment of personnel to successfully complete validation assignments.
• Mentoring non-senior level validation staff.
• Serving as validation representative on cross-functional teams for transfer, NPI, and other projects, supervising contract validation resources.
• Ensuring all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements.
• Supporting and addressing comments and suggestions associated with validation and engineering documentation.
• Change control, non-conformance, and CAPA support.
• Participating 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, or Doctoral degree with 3 years of experience.
• Bachelor's Degree in Engineering (Biomedical, Mechanical, Chemical, 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.
• Excellent organizational and communication skills.
• Results oriented with 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

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

Benefits

• Medical, dental, vision insurance
• Life insurance
• Short- and long-term disability
• Business accident insurance
• Group legal insurance
• Savings plan (401(k))

EEO Statement

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.