Senior Engineer II, Quality Validation

integralife; Braintree (MA); On-site; USD 94,000 - 130,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Job summary

Integra LifeSciences in Massachusetts seeks a Senior Validation Specialist to lead qualification and validation activities for NPI, transfers, and related projects. You will develop and review protocols, support risk analysis, and ensure compliance with cGMP, QSR, ISO and related standards.

The ideal candidate has a strong engineering or science background, 8+ years in validation/QA for medical devices or pharma, and proven project management and technical writing skills.

Qualifications

• 8+ years in validation or quality assurance for medical devices or pharmaceutical environments.
• Excellent organizational and communication skills.
• Results-oriented with a strong focus on quality principles.
• Experience conducting validation studies and managing projects independently.
• Ability to track milestones and manage validation projects.

Responsibilities

• Specialized knowledge in validation areas and contribution to QA processes.
• Prepare, review, and route qualification/validation protocols and summaries.
• Lead risk management activities including PFMEA generation.
• Coordinate scheduling, resources, and documentation for validation assignments.
• Serve as validation representative on cross-functional teams for transfers and NPI.
• Support and address comments on validation and engineering documents.

Skills

Validation expertise

Project management

Regulatory compliance

Technical writing

Education

Bachelor's degree in Engineering or Science

Tools

PFMEA

Job description

Changing 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 Sampling

Responsibilities 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 Salary

Our 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 LifeSciences

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. 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].

Unsolicited Agency Submission

Integra 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.

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