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Process Validation Engineer

Company: Boston Group Executive Offices
Location: woonsocket
Posted on: May 3, 2021

Job Description:

Contract manufacturer specializing in services for medical devices and surgical instruments OEMs is seeking a Process Validation Engineer to be responsible for coordinating and executing various process-intensive internal and customer-facing engineering activities including design, execution and reporting of DOEs. Will define process parameters, qualifications and validations; establishing and conducting process capability studies and implementing effective controls; develop Master Validation Protocols and support Validation & Verification runs and oversee transfer new processes to production; providing technical support to production coating and marking/printing processes: supporting root cause analysis and systematic problem solving of nonconforming products; and supporting customer projects, opportunities, and prototypes/samples. Experience in PPAP (Production Parts Approval Process).

Establish validation standards, develop testing protocols, prepare equipment, document test results, maintain records for analysis and prepare reports for internal and customer use. Interface with customers on technical issues, project timeline, and validation support including coordination of prototypes/samples. Study product characteristics and/or customer requirements and confer with management to determine validation objectives and standards. Responsible for assessing and developing inspection methods, test methods and tools for Operations. Lead, document and execute equipment and process validation activities (IQ, OQ, PQ) on various types of manufacturing equipment, coatings and processes in accordance with ISO- 13485:2016. Facilitate and/or support validation training, continuous improvement process, project management activities as required, and EHS programs. Ensure all processes are running according to specifications and operate within process parameters to ensure the production of quality products. Communicate with regulatory agencies as to compliance documentation or validation results. Develop test strategies and protocols and methods to characterize and verify coating attributes. Conduct Root Cause analysis and implement corrective actions related to non-conforming issues discovered during anodizing and post processing including participation in Material Review Board (MRB), Return Material Authorization (RMA), and Temporary Deviation (TDRA). Institute and apply best engineering practices to processes to ensure effective use of designs, material, equipment and personnel throughout operations. Participate in the development and implementation of facility engineering technology and automation solutions to increase ecological sustainability and operational efficiency. Comfortable working in both laboratory and manufacturing environments.

QUALIFICATIONS:

3-5 years Validation Engineering or relevant experience with Bachelors degree in Engineering, with Chemical Engineering preferred. Experience with quality engineering tools and principles including process validation (IQ/OO/PQ), risk analysis (PFMEA), experimental design (DOE) and Test Method Validations. Ability to apply fundamental engineering principals to resolve issues relating to chemical processing equipment, coating/anodizing processes and product launches. Possess excellent leadership and project management skills capable of multi-tasking and performing assignments that have loosely defined objectives. Sound working knowledge of SPC and statistical tools. Ability to work under tight timelines and be able to motivate others to deliver expected results. Effective team player who can work cross-functionally with Sales, Engineering, Production, and Quality personnel. Must have good verbal, written, and interpersonal skills, capable of professionally handling direct customer communications. Computer Skills (Excel, Word, PowerPoint, Statistics packages, etc.). Ability to apply working knowledge of applicable regulatory standards (FDA, ISO, OSHA, EPA, CFR, etc.) and good understanding in GMP requirements and validation processes

Keywords: Boston Group Executive Offices, Woonsocket , Process Validation Engineer, Other , woonsocket, Rhode Island

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