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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Process Validation Engineer
2 weeks ago
Warsaw, IN, United States Katalyst Healthcares and Life Sciences Full timeJob 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 (21 CFR 820), ISO 13485, and cGMP requirements while collaborating cross-functionally to improve process capability, quality, and efficiency...
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Process Validation Engineer
2 weeks ago
Warsaw, IN, United States Katalyst Healthcares and Life Sciences Full timeJob 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 (21 CFR 820), ISO 13485, and cGMP requirements while collaborating cross-functionally to improve process capability, quality, and efficiency...
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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
1 week 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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Validation Engineer
1 week 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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Validation Engineer
7 days 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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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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Validation/Manufacturing Engineer- CNC
5 days ago
Warsaw, Indiana, United States HCLTech Full timeHCLTech is looking for a highly talented and self- motivated Validation/Manufacturing Engineer- CNC to join it in advancing the technological world through innovation and creativity.Job Title:Validation/Manufacturing Engineer- CNCJob ID:1631955BRPosition Type:Full-time with HCLTechLocation:Warsaw, INRole/ResponsibilitiesRole: Validate CNC equipment and...
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Manufacturing Process Engineer
24 hours ago
Warsaw, IN, United States Kyyba Full timePosition: Manufacturing Process Engineer Type: Contract Location: Warsaw, IN *Job Summary: • Responsible for directing Manufacturing process improvement activities to ensure that the overall business objectives are achieved. • Mechanical Engineering with 4 years' experience in manufacturing process and operations. • Medical domain experience Top...
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Manufacturing Process Engineer
3 days ago
Warsaw, IN, United States Kyyba Full timePosition: Manufacturing Process Engineer Type: Contract Location: Warsaw, IN *Job Summary: • Responsible for directing Manufacturing process improvement activities to ensure that the overall business objectives are achieved. • Mechanical Engineering with 4 years' experience in manufacturing process and operations. • Medical domain experience Top...
