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- Support new product introduction projects through development and execution of process validation and verification test plans, protocols, and report
- Ensure stabilization of new product launches through steady-state processes.
- Monitor the continuous improvement of product requirements, verification strategies, and validation strategies across design and manufacturing changes.
- Support design and process changes throughout commercialization of product lives
- Ensures continued product development compliance with FDA QSR (21 CFR 820), ISO 13485:2016, MDSAP, and other applicable regulations
- Activities would drive prevention, detection of defects to improve/stabilize product launches, continuous improvement & customer satisfaction.
- Provide statistical support, expertise and analytical problem solving for sustaining activities, including development and manufacturing.
- Works directly with internal customers, design, manufacturing and other groups to develop appropriate equipment specifications for calibration and preventative maintenance (PM), such as parameters, intervals, tolerances, acceptance criteria and operating limits for new and existing equipment and systems.
- Ensures inspection and sampling plans, test methods, and transfer functions for products and components are in place and working accordingly
- Participates in investigations of non-conformances, driving consistencies in manufacturing and design
- Contributes to CAPA investigations and solution verification
- Executes projects and assignments with technical responsibility
- Supports the Risk Management process per ISO 14971 and construction / maintenance of the Risk Management File.
- Support the implementation of quality management system (QMS) documentation to ensure compliance with the quality manual and associated Regulations and Standard Operating Procedures (SOPs).
- Plan and direct creation of quality standards, quality control, and quality assurance procedures, sampling plans, test methods, fixtures, and processes for finished devices
- Perform DHF/DHR review for product release.
- Ensures outside supplier quality systems meet requirements and coordinates any activities with the supplier as needed
- Participate in internal, third party and customer audits.
- Assist the Quality Department with other applicable tasks as assigned.
- Bachelor’s degree with 3-5 years of related experience
- Experience working in a cross-functional team environment
- Proficient technical writing skills and use of documentation programs (GoogleDocs, GoogleSheets etc.).
- Working knowledge of fundamental quality and statistical tools and familiarity with a statistical software package (Minitab, JMP, SAS, SPSS, etc.)
- Familiarity with FDA QSR, and ISO 13485 medical device regulations and standards (required); MDSAP (preferred)
- Certified ISO 13485 Lead Auditor a plus
Essential Duties and Responsibilities:
Looking for a highly motivated and experienced Senior Validation Engineer as a subject matter expert in both equipment validation, computer system validation. The Senior Validation Engineer will be responsible to manage and execute validation projects at all sites to maintain QMS compliance with the applicable Standards and Regulations. As the Sr. Validation Engineer, you will be a Subject Matter Expert (SME) and also lead the validation process execution for the organization as well as specific customer project scope with a focus on 3d Additive Manufacturing, GMP Process Equipment, Facilities, and Utilities.
This position requires knowledge of process validation principals, manufacturing controls, and applicable Medical Device standard such as ISO 13485 and QSR 820 requirements. Responsibilities include successful execution of equipment/software validation, providing status updates to ensure all required regulatory requirements are met. Creation and continuous maintenance of a Master Validation Plan (MVP), identify and manage priority and Gantt timeline management.
- Create plan, write and execute (MVP, Equipment Validations, Product Validations and S/W validations, etc.), and manage validation projects while meeting applicable regulatory requirements
- Knowledge of process validation principals, manufacturing controls, and application of medical device standards in accordance with ISO 13485 and FDA 21 CFR 820
- Perform functional and process risk assessments
- Develop and execute Installation, Operational and Performance Qualification (IQ/OQ/PQ) Protocols for various manufacturing and measurement equipment
- Generates, executes and manages validation deliverables under minimal supervision
- Ensures the timely delivery of validation deliverables to allow for validation peer review and RA/QA approval to be completed within the project schedule
- Actively contribute to a variety of projects, which include performing process validations, NPI, nonconformance handling and other quality issues with a focus on Process Equipment, GMP, Facilities, and Utilities
- Operate manufacturing and measurement equipment, and perform process characterization/R&D studies in conjunctions with Manufacturing and R&D
- Acts as a team member in the selection, design, and implementation of new or updated equipment, IT infrastructure, application programs, databases, laboratory equipment automation systems, and/or other hardware to be validated or used in validation projects
- Initiates, reviews and updates detailed system documentation (i.e., Protocols, Reports, etc.) procedures, policies and standards in accordance with regulatory guidelines
- Works with RA/QA Compliance to develop life cycle documentation and validation standards
- Contributes to long-term planning for the Systems Validation business model including team goals, metrics and budget
- Works on problems of complex scope in which analysis of the situation or data requires a review of identifiable factors
- Exercises judgment within defined procedures and practices to determine appropriate action
- Interacts with outside customers and functional peers' groups (Equipment Owners, IT, QA) at various management levels to gain cooperation, foster collaboration and influence project outcomes
- Provides mentoring/training to other personnel
- Conducts presentations of technical information for specific projects or general validation procedures
- Determines validation approach and relevant SOPs on new assignments
- Subject matter expertise of equipment and/or computer systems used in a cGMP environment
- Subject matter expertise of regulatory requirements for equipment and/or computer systems in use for quality products
- May perform other related duties as required and/or assigned
- Bachelor’s Degree in Mechanical/Material Science/Manufacturing Engineering (Masters preferred)
- 8-10+ years validation experience in Medical Device industry (3D Additive a preferred)
- Experience with ISO 13485, ISO 14971, 21 CFR 820 (MDSAP requirements)
- Ability to function efficiently in a fast-paced, dynamic work environment with ability to methodically manage multiples tasks assigned
- Strong background utilizing G-Suite (Google Docs, Google Spreadsheets, Google Slides etc.).
- Experience with Statistical software (Minitab, JMP)
- Working knowledge of Laser Powder Bed Fusion Systems and mechanical testing systems
- Experience with powder metallurgy is a plus
- Prior experience with development and execution of validation documents related to Analytical or Computerized systems
- Knowledge of Data Integrity requirements
- Prior experience in medical, 3D or similar field
- Knowledge of manufacturing concepts and GMP
- While performing this job, the employee may be exposed to moving mechanical equipment, titanium powder, harsh and/or chemicals, biologicals, and excess noise
- Able to walk, stand, reach above the shoulders, use a cellular phone, use feet to operate equipment, stoop, kneel, crouch or crawl, talk, hear, use hands to operate tools and equipment
Job Type: Full-time
Travel: 20% Domestic