Senior Engineer II, Quality Validation

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

Benefits offered by this job

Medical, dental, and vision insurance

401(k) savings plan

Disability and life insurance

Job summary

Integra LifeSciences Corporation in Braintree, MA is hiring a Senior Engineer II for Quality Validation. The role focuses on leading validation projects ensuring compliance with cGMP and managing cross-functional team interactions.

Successful candidates will have a Bachelor’s degree in Engineering or Science and significant experience in quality assurance. The position offers competitive salary and benefits.

Qualifications

• Minimum of 8 years of experience in validation or quality assurance roles.
• Experience in the medical device or pharmaceutical environment required.
• Excellent organizational and communication skills.

Responsibilities

• Conduct validation studies and support new product introduction.
• Mentor non-senior level validation staff.
• Ensure compliance with industry regulations.

Skills

Validation Expertise

Statistical Sampling

Project Management

Technical Writing

Communication Skills

Education

Bachelor's Degree in Engineering or Science

Master's Degree (5 years experience)

Doctoral Degree (3 years experience)

Tools

cGMP Compliance

FDA Inspection Preparation

Job description

## Senior Engineer II, Quality ValidationApplylocations: US-MA-Braintree-220-Facilitytime type: Full timeposted on: Posted Yesterdayjob requisition id: JR-6224Changing lives. Building Careers.Joining us is a chance 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, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.**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 SamplingResponsibilities associated with this position are directly associated 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. 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:* 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 in order to successfully complete validation assignments.* Mentors non-senior level validation staff.* 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**The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.* 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 Pay Range:$94,300.00 - $129,950.00 USD SalaryOur salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training**.** In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation**.** Your recruiter can share more about the specific salary range for your preferred location during the hiring process.Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, Employees are eligible for the following Total Rewards | Integra LifeSciencesIntegra 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. If you'd like more information on your rights under the law, please see the following notices: EEO Is the Law | EOE including Disability/Protected Veterans 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] Agency SubmissionIntegra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.Integra - Employer Branding from Integra LifeSciences on Vimeo### About UsChanging Lives. Building Careers. Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in neurosurgery, reconstructive and general surgery, and regenerative wound care. Founded in 1989 Integra is headquartered in Princeton, New Jersey and has more than 4,000 employees worldwide. Integra’s common stock is listed on The NASDAQ Stock Market under the symbol “IART.”