Senior Engineer II, Quality Validation

Integra LifeSciences•Braintree, MA

8d•$94,300 - $129,950

About The Position

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.

Requirements

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.
An understanding of clean room practice and cGMP environments is required.
Must understand the concepts of risk management and the ability to identify and classify critical parameters within a production setting.
Must be well organized and technically sound in understanding scientific rationale and justifying acceptance criteria from a quantitative standpoint.
Must understand risk-based sampling.
Possess sufficient knowledge and experience to serve as a subject matter expert within one area of validation.

Nice To Haves

Packaging Validation
Equipment Qualification
Process Validation
Test Method Validation
Cleaning Validation
Utility / Clean Room Validation
Temperature Mapping Studies
Statistical Sampling

Responsibilities

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.