Kindeva Drug Delivery Company
Senior Process Development Engineer II
Kindeva Drug Delivery Company, Lexington, Kentucky, us, 40598
Posted Monday, December 15, 2025 at 6:00 AM
Our Work Matters At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make: Join a rapidly expanding pharmaceutical CDMO where your work directly enhances the scalability and efficiency of life‑changing treatments. As a Senior Process Development Engineer, you will lead and coordinate the transfer of pharmaceutical products and manufacturing processes between R&D and commercial manufacturing sites. You’ll ensure processes are scalable, robust, and compliant with regulatory standards. Your expertise will shape systems, equipment, and SOPs while supporting the production of finished pharmaceutical products.
Responsibilities:
Plan and execute technology transfer activities for drug products or devices from R&D to manufacturing or between commercial sites
Author and/or review tech transfer documentation (e.g., process descriptions, gap assessments, risk assessments, readiness assessments, protocols)
Process Optimization & Troubleshooting
Support scale‑up activities and resolve technical issues during manufacturing
Work with R&D to adapt and optimize processes for commercial equipment
Implement process improvements to enhance product quality, yield, and efficiency
Documentation & Compliance
Ensure all tech transfer activities are documented per regulatory requirements
Support regulatory submissions and inspections/audits
Draft production documentation including batch records and protocols
Support validation and qualification efforts (process, equipment, cleaning)
Cross-Functional Collaboration
Serve as technical liaison between engineering, R&D, manufacturing, QA, and regulatory
Coordinate with customers, vendors, and external partners
Training & Support
Train manufacturing staff on transferred processes
Facilitate knowledge transfer and review development history
Troubleshoot and elevate risks with proposed mitigation strategies
Ensure effective and compliant transfer of knowledge, data, and technology
Problem Solving
Apply scientific and statistical methods to analyze and diagram production processes
Lead structured problem‑solving to identify root causes and develop solutions
Drive Risk Management tools like Fault Tree Analysis and FMEA
Address diverse technical problems requiring informed judgment and adaptive techniques
Provide technical leadership and guidance to others as a subject matter expert
Qualifications: Minimum Qualifications Required
BS in engineering/related degree or equivalent experience
8+ years of related experience with a bachelor’s degree; or 6 years with a master’s degree, or 3 years and a PhD.
Previous work experience in GMP pharmaceutical manufacturing and technical transfers
Working knowledge of cGMP, GAMP5, and regulatory requirements
Preferred Qualifications
Experience working with nasal spray products/devices or related drug‑delivery technologies
Strong technical and nontechnical communication skills
Experience supporting client/regulatory audits and follow‑up responses
Extensive technical writing experience
Join our One Team mission of manufacturing more tomorrows. Your expertise will help ensure better health and well‑being for patients worldwide.
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!
#J-18808-Ljbffr
Our Work Matters At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make: Join a rapidly expanding pharmaceutical CDMO where your work directly enhances the scalability and efficiency of life‑changing treatments. As a Senior Process Development Engineer, you will lead and coordinate the transfer of pharmaceutical products and manufacturing processes between R&D and commercial manufacturing sites. You’ll ensure processes are scalable, robust, and compliant with regulatory standards. Your expertise will shape systems, equipment, and SOPs while supporting the production of finished pharmaceutical products.
Responsibilities:
Plan and execute technology transfer activities for drug products or devices from R&D to manufacturing or between commercial sites
Author and/or review tech transfer documentation (e.g., process descriptions, gap assessments, risk assessments, readiness assessments, protocols)
Process Optimization & Troubleshooting
Support scale‑up activities and resolve technical issues during manufacturing
Work with R&D to adapt and optimize processes for commercial equipment
Implement process improvements to enhance product quality, yield, and efficiency
Documentation & Compliance
Ensure all tech transfer activities are documented per regulatory requirements
Support regulatory submissions and inspections/audits
Draft production documentation including batch records and protocols
Support validation and qualification efforts (process, equipment, cleaning)
Cross-Functional Collaboration
Serve as technical liaison between engineering, R&D, manufacturing, QA, and regulatory
Coordinate with customers, vendors, and external partners
Training & Support
Train manufacturing staff on transferred processes
Facilitate knowledge transfer and review development history
Troubleshoot and elevate risks with proposed mitigation strategies
Ensure effective and compliant transfer of knowledge, data, and technology
Problem Solving
Apply scientific and statistical methods to analyze and diagram production processes
Lead structured problem‑solving to identify root causes and develop solutions
Drive Risk Management tools like Fault Tree Analysis and FMEA
Address diverse technical problems requiring informed judgment and adaptive techniques
Provide technical leadership and guidance to others as a subject matter expert
Qualifications: Minimum Qualifications Required
BS in engineering/related degree or equivalent experience
8+ years of related experience with a bachelor’s degree; or 6 years with a master’s degree, or 3 years and a PhD.
Previous work experience in GMP pharmaceutical manufacturing and technical transfers
Working knowledge of cGMP, GAMP5, and regulatory requirements
Preferred Qualifications
Experience working with nasal spray products/devices or related drug‑delivery technologies
Strong technical and nontechnical communication skills
Experience supporting client/regulatory audits and follow‑up responses
Extensive technical writing experience
Join our One Team mission of manufacturing more tomorrows. Your expertise will help ensure better health and well‑being for patients worldwide.
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!
#J-18808-Ljbffr