Kindeva Drug Delivery
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Senior Manufacturing Engineer II
role at
Kindeva Drug Delivery
Our Work Matters At Kindeva we make products that save lives, ensuring better health and well‑being for patients around the world.
Impact You Will Make As a Sr. Manufacturing Engineer II, you will play a critical role in driving manufacturing excellence through process optimisation, equipment innovation and cross‑functional collaboration. By leading initiatives that enhance productivity, quality and compliance, you will directly contribute to improved operational performance and product reliability. Your ability to develop and implement scalable manufacturing solutions, resolve complex technical challenges, and partner with stakeholders will support continuous improvement and long‑term business success. With a hands‑on, data‑driven approach, your expertise will help shape efficient, cost‑effective, and compliant manufacturing processes that align with company goals and customer expectations.
Responsibilities
Equipment Performance and Troubleshooting
Lead efforts to monitor and optimise the performance of manufacturing equipment, ensuring compliance with CGMP standards.
Troubleshoot and resolve complex issues to minimise production downtime.
Identify and implement opportunities for continuous improvement through upgrades, process modification or alternative solutions. Lead in the development and implementation of procedural or automation improvement changes.
Lead lean manufacturing initiatives, Six Sigma projects and other process optimisation efforts to improve productivity, quality and cost efficiency.
Assist with new product/equipment design reviews, process development and commercialisation activities, including training and development of manufacturing staff on operation and process.
Serve as a technical point of contact for client and contract services.
Data Analytics and Performance Analysis
Develop and maintain measurement systems to visualise manufacturing key performance indicators (KPIs).
Use data analytics tools and techniques to analyse equipment performance, identify trends and recommend corrective action and process improvement.
Quality System / Equipment Qualification Support
Assist with manufacturing equipment‑related deviations and root cause analysis as the equipment SME.
Support the development and execution of Corrective and Preventive Actions (CAPA) and Change Controls to address root causes of equipment failures and performance issues.
Support equipment Installation, Operation and Performance Qualification (IOPQ) activities.
Experience supporting client and regulatory audits as well as responding to action items.
Provide SME input on equipment qualification processes, ensuring fit for commercial manufacturing use, compliance with FDA and other regulatory requirements.
Qualifications Basic Qualifications
Bachelor’s degree in Engineering or related field and/or equivalent experience
8+ years of manufacturing and relevant experience in the pharmaceutical industry with a Bachelor’s degree; or 6+ years’ experience in the pharmaceutical industry and a Master’s degree or a PhD with 3 years in the pharmaceutical industry and a focus on equipment and process improvement.
Proven track record of successfully implementing improvement initiatives in a pharmaceutical manufacturing environment.
Strong analytical and problem‑solving skills with the ability to use data to drive decision‑making.
Excellent communication and interpersonal skills, with the ability to influence and collaborate effectively across multiple departments.
Ability to manage multiple projects and priorities in a fast‑paced environment.
Technical writing experience, such as SOPs, Maintenance PMs, user requirement specs, vendor requests for proposal
Experience with automation, nasal, or related drug delivery device manufacture and packaging.
Preferred Qualifications
Lean manufacturing or Six Sigma certifications
Proficiency in using Lean tools and software applications such as Smartsheet, Power BI, Power Apps, etc.
Experience with site‑level automation systems, e.g.
Serialization - Antares, Tracelink
Data historian – Aveva OSI PI
Reporting Systems – OSI PI, MS Report Builder, SQL Development
Kepware, Matrikon, AB Factory Talk
Automated Visual Inspection
Other duties as assigned
Physical Requirements
Specific vision requirements include close vision, distance vision, colour vision and the ability to adjust and focus to read/understand/execute documentation as required by the position.
Employees are required to follow all current Good Manufacturing Practice (cGMP) and safety procedures.
The employee must wear all required safety equipment and safely perform assigned work.
Employees must use proper lifting techniques and be aware of hazards around them.
Must follow all GMP and safety procedures within the department.
The employee must occasionally lift and/or move up to 20 pounds.
Equal Opportunity Employer Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, colour, 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!
#J-18808-Ljbffr
Senior Manufacturing Engineer II
role at
Kindeva Drug Delivery
Our Work Matters At Kindeva we make products that save lives, ensuring better health and well‑being for patients around the world.
Impact You Will Make As a Sr. Manufacturing Engineer II, you will play a critical role in driving manufacturing excellence through process optimisation, equipment innovation and cross‑functional collaboration. By leading initiatives that enhance productivity, quality and compliance, you will directly contribute to improved operational performance and product reliability. Your ability to develop and implement scalable manufacturing solutions, resolve complex technical challenges, and partner with stakeholders will support continuous improvement and long‑term business success. With a hands‑on, data‑driven approach, your expertise will help shape efficient, cost‑effective, and compliant manufacturing processes that align with company goals and customer expectations.
Responsibilities
Equipment Performance and Troubleshooting
Lead efforts to monitor and optimise the performance of manufacturing equipment, ensuring compliance with CGMP standards.
Troubleshoot and resolve complex issues to minimise production downtime.
Identify and implement opportunities for continuous improvement through upgrades, process modification or alternative solutions. Lead in the development and implementation of procedural or automation improvement changes.
Lead lean manufacturing initiatives, Six Sigma projects and other process optimisation efforts to improve productivity, quality and cost efficiency.
Assist with new product/equipment design reviews, process development and commercialisation activities, including training and development of manufacturing staff on operation and process.
Serve as a technical point of contact for client and contract services.
Data Analytics and Performance Analysis
Develop and maintain measurement systems to visualise manufacturing key performance indicators (KPIs).
Use data analytics tools and techniques to analyse equipment performance, identify trends and recommend corrective action and process improvement.
Quality System / Equipment Qualification Support
Assist with manufacturing equipment‑related deviations and root cause analysis as the equipment SME.
Support the development and execution of Corrective and Preventive Actions (CAPA) and Change Controls to address root causes of equipment failures and performance issues.
Support equipment Installation, Operation and Performance Qualification (IOPQ) activities.
Experience supporting client and regulatory audits as well as responding to action items.
Provide SME input on equipment qualification processes, ensuring fit for commercial manufacturing use, compliance with FDA and other regulatory requirements.
Qualifications Basic Qualifications
Bachelor’s degree in Engineering or related field and/or equivalent experience
8+ years of manufacturing and relevant experience in the pharmaceutical industry with a Bachelor’s degree; or 6+ years’ experience in the pharmaceutical industry and a Master’s degree or a PhD with 3 years in the pharmaceutical industry and a focus on equipment and process improvement.
Proven track record of successfully implementing improvement initiatives in a pharmaceutical manufacturing environment.
Strong analytical and problem‑solving skills with the ability to use data to drive decision‑making.
Excellent communication and interpersonal skills, with the ability to influence and collaborate effectively across multiple departments.
Ability to manage multiple projects and priorities in a fast‑paced environment.
Technical writing experience, such as SOPs, Maintenance PMs, user requirement specs, vendor requests for proposal
Experience with automation, nasal, or related drug delivery device manufacture and packaging.
Preferred Qualifications
Lean manufacturing or Six Sigma certifications
Proficiency in using Lean tools and software applications such as Smartsheet, Power BI, Power Apps, etc.
Experience with site‑level automation systems, e.g.
Serialization - Antares, Tracelink
Data historian – Aveva OSI PI
Reporting Systems – OSI PI, MS Report Builder, SQL Development
Kepware, Matrikon, AB Factory Talk
Automated Visual Inspection
Other duties as assigned
Physical Requirements
Specific vision requirements include close vision, distance vision, colour vision and the ability to adjust and focus to read/understand/execute documentation as required by the position.
Employees are required to follow all current Good Manufacturing Practice (cGMP) and safety procedures.
The employee must wear all required safety equipment and safely perform assigned work.
Employees must use proper lifting techniques and be aware of hazards around them.
Must follow all GMP and safety procedures within the department.
The employee must occasionally lift and/or move up to 20 pounds.
Equal Opportunity Employer Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, colour, 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!
#J-18808-Ljbffr