Senior Validation Engineer I
3 days ago
Changing lives. Building Careers. Joining us is a chance for you 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, more than 4,000 of us are challenging what's possible and making headway to help improve outcomes. 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: Equipment Qualification Process Validation Test Method Validation Cleaning Validation Statistical Sampling Responsibilities associated with this position are directly associated to conducting validations related to new product introduction (NPI), product transfers, and other validation projects. Well organized and technically sound in understanding scientific rationale and justifying acceptance criteria from a quantitative standpoint. Understand risk-based sampling. Candidate must possess sufficient knowledge and experience to serve as a subject matter expert within one area of validation. 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 cGMP environments is required. 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: Generation and execution of qualification/validation protocols including the generation, routing and approval of summary documentation. Determine scope and path forward for validation requests. 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. 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. The requirements listed below are representative of the knowledge, skill, and/or ability required for this position. Bachelor's degree in engineering (Quality, Mechanical, Chemical, or Electrical) or Science (Biology, Chemistry) in preferred. 4-7 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.
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Senior Production Engineer
2 hours ago
Mansfield, Ohio, United States Tekhawks LLC Full timeAbout the RoleWe are currently seeking an experienced Senior Production Engineer to join our team at Tekhawks LLC. This is a fantastic opportunity for a motivated individual who wants to take their career to the next level.The successful candidate will have a strong background in manufacturing processes, with experience in lean manufacturing and six sigma...
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Senior Quality Engineer Position
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Mansfield, Massachusetts, United States Integra LifeSciences Full timeIntegra LifeSciences is an equal opportunity employer committed to providing a dynamic work environment that fosters growth, innovation, and excellence. We're seeking a highly skilled Senior Quality Systems Engineer to join our team.The estimated salary for this position is $140,000 - $200,000 per year, depending on your location and experience.About the...
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Senior Substation Physical Design Engineer
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Mansfield, United States ControlPoint Technologies Full timeAbout the Senior Substation Engineer position ControlPoint Technologies is seeking a Senior Substation Engineer to provide project support within our Substation Engineering team. Candidates must have direct experience with Transmission and/or Distribution Substation Projects. Ability to work within engineering design standards and quality programs specific...
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Senior Quality Assurance Engineer
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Mansfield, Massachusetts, United States Volt Full timeAbout the RoleWe are seeking a seasoned Senior Quality Assurance Engineer - Process Excellence to join our team at Volt. As a key member of our quality team, you will play a vital role in ensuring the highest standards of quality and process excellence.
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Senior Quality Assurance Engineer
3 weeks ago
Mansfield, Massachusetts, United States Volt Full timeJob Summary:Volt is currently seeking a highly skilled and experienced Senior Quality Assurance Engineer to join their team in Mansfield, MA.Key Responsibilities:Develop and implement effective risk management strategies to prevent unanticipated failures and improve process capability.Support business processes and supervise, lead, and mentor engineers and...
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Substation Design Engineering Lead
1 week ago
Mansfield, Massachusetts, United States ControlPoint Technologies Full timeAbout the RoleControlPoint Technologies is a leading provider of substation engineering services, and we are seeking a highly skilled Senior Substation Physical Design Engineer to join our team.
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Senior Substation Design Engineer
3 weeks ago
Mansfield, Massachusetts, United States ControlPoint Technologies Full timeAbout the RoleAt ControlPoint Technologies, we are seeking an experienced Lead Substation Physical Design Engineer to provide project support within our Substation Engineering team. As a seasoned professional with direct experience in Transmission and/or Distribution Substation Projects, you will play a key role in delivering high-quality projects that meet...
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Manufacturing Engineer II
4 weeks ago
Mansfield, United States Intellectt Inc Full timeRole: Manufacturing Engineer IILocation: Mansfield, MA - 2048Duration: 8 MonthsJob Description:Primary responsibilities are to:• Create, update, and maintain equipment service work instructions.• Organize and write validation protocols associated with the manufacturing process• Lead and support troubleshooting activities to minimize process downtime or...
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Manufacturing Engineer II
4 weeks ago
Mansfield, United States Intellectt Inc Full timeRole: Manufacturing Engineer IILocation: Mansfield, MA - 2048Duration: 8 MonthsJob Description:Primary responsibilities are to:• Create, update, and maintain equipment service work instructions.• Organize and write validation protocols associated with the manufacturing process• Lead and support troubleshooting activities to minimize process downtime or...
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Life Enrichment
2 months ago
Mansfield, United States Legend Senior Living Full timeLegend Senior Living is proud to be recognized as a Certified Great Places to Work 6 years in a row! Legend of Mansfield is proud to be part of the Legend Senior Living family and we are Hiring! A career with us quality training, plenty of growth and development opportunities and a team that feels like family. We are looking for outstanding individuals to...
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Manufacturing Engineer III
3 days ago
Mansfield, United States Integrated Resources Full timeJob Title: Manufacturing Engineer III Location: Mansfield, MA 02048 Duration: 6 Months+ - Possibility of Extension Pay range: $44 - $53.48/hr. on w2Essential Duties And Responsibilities To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Maintain and Support new and existing Operations Equipment...
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Quality Engineering Team Lead
7 days ago
Mansfield, Massachusetts, United States Integra LifeSciences Full timeResponsibilitiesDraw on experience with root cause analysis, design verification/validation, statistical methods, and technical specification review to complete new product development and validation.Expertly provide quality and engineering decisions in a manufacturing environment.Lead moderate to significant engineering improvements to quality and...
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Manufacturing Engineer II_US
3 weeks ago
Mansfield, United States Volt Workforce Solution Full timeJob DescriptionJob DescriptionYou deserve a job you love! Volt is immediately hiring a Manufacturing Engineer located in Mansfield, MA As a Manufacturing Engineer you will:Create, update, and maintain equipment service work instructions.Organize and write validation protocols associated with the manufacturing processLead and support troubleshooting...
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Senior Quality Assurance Engineer
6 days ago
Mansfield, Massachusetts, United States Randstad Full timeAbout the Role:We are seeking an experienced Quality Assurance Engineer to join our team in Mansfield, MA. The successful candidate will be responsible for ensuring the quality of our products and processes, working closely with cross-functional teams to identify and implement improvements.
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Manufacturing Engineer II
3 weeks ago
Mansfield, Ohio, United States Intellectt Inc Full timeJob Summary:We are seeking a skilled Manufacturing Engineer II to join our team at Intellectt Inc. in Mansfield, MA.About the Role:This is an exciting opportunity for a highly motivated and experienced professional to lead process improvements in our manufacturing operations.Key Responsibilities:As a Manufacturing Engineer II, you will be responsible for...
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Senior Electrical Engineer
7 hours ago
Mansfield, Massachusetts, United States ControlPoint Technologies Full timeAbout the RoleThe successful candidate will have extensive experience in electrical distribution planning for utilities, with a strong background in project management and leadership. You will be responsible for managing multiple projects simultaneously, developing project plans, and ensuring timely delivery of high-quality results.About the...
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Senior Quality Assurance Specialist
8 hours ago
Mansfield, Massachusetts, United States Integra LifeSciences Full timeAbout the RoleAs a Senior Quality Systems Engineer at Integra LifeSciences, you will play a critical role in supporting our site's Quality Management System (QMS). This position requires strong analytical skills, exceptional writing and interpersonal relationship skills, or a combination of relevant work experience and education. The estimated salary for...
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quality engineer
1 week ago
Mansfield, United States Randstad Full timequality engineer. mansfield , massachusetts posted november 25, 2024 job details summary $40.29 - $56.28 per hour contract bachelor degree category computer and mathematical occupations reference1073314 job details job summary: A Quality Engineer is needed for a world leader in medical devices that seeks to offer innovative solutions in...
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mansfield, United States Intellectt Inc Full timeRole: Manufacturing Engineer IILocation: Mansfield, MA - 2048Duration: 8 MonthsJob Description:Primary responsibilities are to:• Create, update, and maintain equipment service work instructions.• Organize and write validation protocols associated with the manufacturing process• Lead and support troubleshooting activities to minimize process downtime or...
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Senior Technical Service Specialist
3 weeks ago
Mansfield, Ohio, United States SPECS-TII Inc. Full timeJob OverviewSPECS-TII Inc. is a leading provider of ultra-high vacuum (UHV) surface analysis instrumentation in North America.We are seeking a highly skilled Senior Technical Service Specialist to join our team, providing on-site service, maintenance, and repair of customer equipment.ResponsibilitiesSupport USA and Canadian customers on technical questions...