Kindeva Drug Delivery Company
The Impact You Will Make
The Manufacturing Engineer – Visual Inspection (ME) serves as the technical leader and process owner for critical manufacturing equipment and systems, with a focus on innovation, reliability, and operational excellence. This role drives continuous improvement through cross-functional collaboration, vision systems optimization, and advanced problem-solving. As a key contributor to site performance, the ME leads initiatives that enhance equipment effectiveness, reduce costs, and ensure robust process capability to support compliant, efficient, and high-quality operations. This position requires independent judgment to resolve complex technical challenges and regularly engages senior leadership by providing progress updates on critical manufacturing projects, compliance status, equipment modifications, process deviation resolutions, and strategic recommendations for future business. Role Responsibilities
Primary Operations contact for technical performance and continuous improvement of assigned visual inspection equipment. Act as the go-to SME for operations engineering support. Lead development and integration of vision systems, including deep learning (AI) solutions, to optimize defect detection and increase production efficiency. Maintain and evolve AI/machine learning expertise. Responsible person for cost reduction and lean initiatives to improve OEE, yield, and capacity while driving toward “zero defects”. Lead cross-functional projects supporting new product introductions, equipment upgrades and process improvement activities, from concept through validation and production hand-off. Apply structured problem-solving techniques (e.g., Six Sigma, DMAIC, 5 Whys) to investigate deviations, reduce recurring issues, and implement sustainable corrective and preventive actions (CAPAs). Act as a change owner and driver for equipment, process, and system improvements—leading change control efforts, coordinating cross-functional input, and ensuring timely, compliant execution with clear task ownership and follow-through. Act as a technical trainer for Operations and Maintenance teams. Develop training on systems, tools, and troubleshooting techniques to promote equipment/process ownership. Collaborate extensively with cross-functional stakeholders—including QA, Automation, Validation, OPEX, and Tech Services—to deliver high-impact process improvements that align with site KPIs. Design and execute technical investigations and system studies, including equipment challenges and capability assessments, to support performance improvement and validation readiness. Leverage data analytics to support real-time monitoring, trend analysis, and continuous improvement of process reliability and product quality. Engage senior leadership by clearly communicating technical concepts, project status, risks, and recommendations; adapt communication style to diverse audiences and provide expert advice on challenging manufacturing and automation issues. Qualifications
Bachelor’s degree (or higher) in Engineering or a Science-related field 5+ years of experience in cGMP, FDA-regulated pharmaceutical manufacturing. Proven ability to lead cross-functional projects, manage change controls, and drive site-wide initiatives across departments. Demonstrated experience with continuous improvement initiatives focused on equipment and process reliability, and cost reduction. Excellent communication skills, with the ability to simplify and present complex technical concepts to both senior leadership and shop floor teams. Strong foundation in process improvement methodologies (e.g., Six Sigma, Lean, DMAIC) and root cause analysis techniques. Proficient in computerized systems including Microsoft Office, Power BI, and Smartsheets (or equivalent). Capable of developing technical training for operations and maintenance personnel to drive equipment ownership and troubleshooting competency. Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral. Equal Opportunity Employer: Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. Do you see yourself as part of the Kindeva mission? Click Apply Now Today! Job Family B - Engineering - Manufacturing Engineering
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The Manufacturing Engineer – Visual Inspection (ME) serves as the technical leader and process owner for critical manufacturing equipment and systems, with a focus on innovation, reliability, and operational excellence. This role drives continuous improvement through cross-functional collaboration, vision systems optimization, and advanced problem-solving. As a key contributor to site performance, the ME leads initiatives that enhance equipment effectiveness, reduce costs, and ensure robust process capability to support compliant, efficient, and high-quality operations. This position requires independent judgment to resolve complex technical challenges and regularly engages senior leadership by providing progress updates on critical manufacturing projects, compliance status, equipment modifications, process deviation resolutions, and strategic recommendations for future business. Role Responsibilities
Primary Operations contact for technical performance and continuous improvement of assigned visual inspection equipment. Act as the go-to SME for operations engineering support. Lead development and integration of vision systems, including deep learning (AI) solutions, to optimize defect detection and increase production efficiency. Maintain and evolve AI/machine learning expertise. Responsible person for cost reduction and lean initiatives to improve OEE, yield, and capacity while driving toward “zero defects”. Lead cross-functional projects supporting new product introductions, equipment upgrades and process improvement activities, from concept through validation and production hand-off. Apply structured problem-solving techniques (e.g., Six Sigma, DMAIC, 5 Whys) to investigate deviations, reduce recurring issues, and implement sustainable corrective and preventive actions (CAPAs). Act as a change owner and driver for equipment, process, and system improvements—leading change control efforts, coordinating cross-functional input, and ensuring timely, compliant execution with clear task ownership and follow-through. Act as a technical trainer for Operations and Maintenance teams. Develop training on systems, tools, and troubleshooting techniques to promote equipment/process ownership. Collaborate extensively with cross-functional stakeholders—including QA, Automation, Validation, OPEX, and Tech Services—to deliver high-impact process improvements that align with site KPIs. Design and execute technical investigations and system studies, including equipment challenges and capability assessments, to support performance improvement and validation readiness. Leverage data analytics to support real-time monitoring, trend analysis, and continuous improvement of process reliability and product quality. Engage senior leadership by clearly communicating technical concepts, project status, risks, and recommendations; adapt communication style to diverse audiences and provide expert advice on challenging manufacturing and automation issues. Qualifications
Bachelor’s degree (or higher) in Engineering or a Science-related field 5+ years of experience in cGMP, FDA-regulated pharmaceutical manufacturing. Proven ability to lead cross-functional projects, manage change controls, and drive site-wide initiatives across departments. Demonstrated experience with continuous improvement initiatives focused on equipment and process reliability, and cost reduction. Excellent communication skills, with the ability to simplify and present complex technical concepts to both senior leadership and shop floor teams. Strong foundation in process improvement methodologies (e.g., Six Sigma, Lean, DMAIC) and root cause analysis techniques. Proficient in computerized systems including Microsoft Office, Power BI, and Smartsheets (or equivalent). Capable of developing technical training for operations and maintenance personnel to drive equipment ownership and troubleshooting competency. Kindeva does not accept unsolicited assistance from headhunters or recruitment firms for any of our job openings. Any resumes or candidate profiles submitted to Kindeva employees—regardless of format—without a valid, signed agreement and an approved job order from an authorized signatory in Talent Acquisition will be considered the sole property of Kindeva. No fees will be paid in the event that a candidate is hired as a result of an unsolicited resume or referral. Equal Opportunity Employer: Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. Do you see yourself as part of the Kindeva mission? Click Apply Now Today! Job Family B - Engineering - Manufacturing Engineering
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