Process Validation Engineer
2 weeks ago
Job Summary: The Process Validation Engineer supports medical device manufacturing by developing, executing, and maintaining validated manufacturing and test processes. The role ensures compliance with FDA QSR ( CFR ), ISO , and cGMP requirements while collaborating cross-functionally to improve process capability, quality, and efficiency across a variety of manufacturing operations. Roles & Responsibilities: Develop and execute process validation strategies, including process characterization and creation of IQ, OQ, and PQ protocols and reports. Perform equipment IQ/OQ, process OQ/PQ, test method validation, and Gage R&R studies. Ensure regulatory compliance with FDA QSR, ISO , and internal quality system requirements; participate in audits as needed. Compile, analyze, and interpret validation and SPC data; identify trends and opportunities for continuous improvement. Lead root cause analysis and problem-solving activities for technical and process-related issues using quality and statistical tools. Support and lead change management activities including Change Management System, Nonconformance Reports, CAPA, Engineering Specifications, and Work Instructions. Create, maintain, and improve controlled technical documentation such as prints, procedures, bills of materials (BOM), and routers. Establish, evaluate, and improve manufacturing process methods that meet performance, quality, and CTQ requirements. Conduct feasibility studies to estimate product cost and analyze capital equipment, capacity, and capability requirements. Support a wide variety of manufacturing processes including machining, finishing, forging, casting, cleaning, heat treating, bonding, and molding. Collaborate cross-functionally with Manufacturing, Quality Assurance, Engineering, and other teams to resolve issues, implement strategies, and provide technical support. Develop and execute project plans and schedules; prioritize multiple medium-complexity projects and communicate progress effectively. Communicate project plans and technical direction clearly through written and verbal communication with cross-functional teams. Read and interpret engineering drawings and specifications to support manufacturing and validation activities. • Education & Experience: – years of experience supporting medical device manufacturing process validations. Working knowledge of design control, FDA QSR ( CFR ), ISO :, and cGMP requirements. Proficiency in statistical tools including SPC, PFMEA, CTQ analysis, and general statistics. Experience with Microsoft Office Suite and Microsoft Project. Strong written and verbal communication skills with the ability to work effectively in cross-functional teams.
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Validation Engineer
1 week ago
Warsaw, United States Katalyst HealthCares & Life Sciences Full timeSummary: Role: Lead and Validate CNC equipment and related processes used to manufacture medical devices. Focus: Ensure IQ/OQ/PQ, calibration, traceability, and compliance with GMP/ISO standards in a regulated MedTech environment. Aim: Ensure robust, reproducible manufacturing processes and maintain inspection-ready documentation. Roles & Responsibilities:...
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Validation Engineer
2 weeks ago
Warsaw, IN, United States Katalyst Healthcares and Life Sciences Full timeSummary: Role: Lead and Validate CNC equipment and related processes used to manufacture medical devices. Focus: Ensure IQ/OQ/PQ, calibration, traceability, and compliance with GMP/ISO standards in a regulated MedTech environment. Aim: Ensure robust, reproducible manufacturing processes and maintain inspection-ready documentation. Roles & Responsibilities: ...
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Senior Validation Engineer
7 days ago
Warsaw, United States Katalyst HealthCares & Life Sciences Full timeRoles & Responsibilities: Develops and Executes Process Validation Strategies Creates plans, protocols (IQ, OQ, PQ), and risk assessments to ensure effective processes for medical devices and equipment. Ensures Regulatory Compliance Adheres to FDA ( CFR ), ISO , and other relevant regulations, participating in audits and maintaining up-to-date knowledge....
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Software Validation Engineer III
2 weeks ago
Warsaw, Indiana, United States Collabera Full timeCompany Description Collabera Inc (Staffing Firm). We are based out of Morristown, NJ and we have been providing contingent labor to our clients for last 25 years. In 2015 we placed more than 6,000 contractors across select 100+ clients that we service. End client for this project is a large legal organization with operations in more than 100 countries and...
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Manufacturing Validation Engineer
2 weeks ago
Warsaw, IN, United States CData Software Full timeUPDATED RGS: 283819 MOST CRITICAL need profiles by 2pmEST Please share profiles for below requirement, ASAP Job ID Account Name Skill Location Max Salary Range Zimmer Manufacturing Validation Engineer Warsaw, IN 72k
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Process Engineer
2 weeks ago
Warsaw, United States Avero Full timeA company in Warsaw, IN, is looking for a hands-on, detail-oriented Process Engineer to join their manufacturing team. This role supports an investment casting operation that produces precision metal components for highly regulated and performance-driven industries, including medical devices, aerospace, and industrial applications. In this position, you...
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Process Engineer
2 weeks ago
Warsaw, Indiana, United States Avero Full timeA company in Warsaw, IN, is looking for a hands-on, detail-oriented Process Engineer to join their manufacturing team. This role supports an investment casting operation that produces precision metal components for highly regulated and performance-driven industries, including medical devices, aerospace, and industrial applications.In this position, you will...
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Process Engineer
1 week ago
Warsaw, IN, United States Avero Full timeA company in Warsaw, IN, is looking for a hands-on, detail-oriented Process Engineer to join their manufacturing team. This role supports an investment casting operation that produces precision metal components for highly regulated and performance-driven industries, including medical devices, aerospace, and industrial applications. In this position, you...
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Process Engineer
1 week ago
Warsaw, IN, United States Avero Full timeA company in Warsaw, IN, is looking for a hands-on, detail-oriented Process Engineer to join their manufacturing team. This role supports an investment casting operation that produces precision metal components for highly regulated and performance-driven industries, including medical devices, aerospace, and industrial applications. In this position, you...
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Process Engineer, Body
2 weeks ago
Warsaw, IN, United States Slate Auto Full timeABOUT SLATE At Slate, we're building safe, reliable vehicles that people can afford, personalize and love-and doing it here in the USA as part of our commitment to reindustrialization. The spirit of DIY and customization runs throughout every element of a Slate, because people should have control over how their trucks look, feel, and represent them. WHO WE...
