Kindeva Drug Delivery
Join to apply for the
Senior Process Development Engineer
role at
Kindeva Drug Delivery 1 day ago Be among the first 25 applicants Join to apply for the
Senior Process Development Engineer
role at
Kindeva Drug Delivery Our Work Matters
Make sure to read the full description below, and please apply immediately if you are confident you meet all the requirements.
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
Collaborative team culture Direct impact on patient care Our Work Matters
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
Why Kindeva?
Purpose-driven work environment Significant growth potential Collaborative team culture Direct impact on patient care Industry-leading innovation
At Kindeva – Lexington, KY, we're not just making products – we're manufacturing life-saving nasal spray medications that make a difference.
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.
Growth Opportunity
Our Lexington facility is experiencing exponential growth, offering exceptional opportunities for professional development and advancement. Join us during this exciting expansion phase and grow your career while contributing to meaningful healthcare solutions.
Responsibilities
Technology Transfer
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) Translate lab-scale processes into commercial manufacturing processes
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 escalate 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 5+ years of related experience with a Bachelor’s degree; or 3 years with a Master’s degree 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.
# LI-Onsite
California residents should review our
Notice for California Employees and Applicants
before applying.
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!Seniority level
Seniority levelMid-Senior level Employment type
Employment typeFull-time Job function
Job functionEngineering and Information Technology IndustriesPharmaceutical Manufacturing Referrals increase your chances of interviewing at Kindeva Drug Delivery by 2x Sign in to set job alerts for “Senior Process Development Engineer” roles. Lexington, KY $107,763.51-$143,684.69 1 week ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Senior Process Development Engineer
role at
Kindeva Drug Delivery 1 day ago Be among the first 25 applicants Join to apply for the
Senior Process Development Engineer
role at
Kindeva Drug Delivery Our Work Matters
Make sure to read the full description below, and please apply immediately if you are confident you meet all the requirements.
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
Collaborative team culture Direct impact on patient care Our Work Matters
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
Why Kindeva?
Purpose-driven work environment Significant growth potential Collaborative team culture Direct impact on patient care Industry-leading innovation
At Kindeva – Lexington, KY, we're not just making products – we're manufacturing life-saving nasal spray medications that make a difference.
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.
Growth Opportunity
Our Lexington facility is experiencing exponential growth, offering exceptional opportunities for professional development and advancement. Join us during this exciting expansion phase and grow your career while contributing to meaningful healthcare solutions.
Responsibilities
Technology Transfer
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) Translate lab-scale processes into commercial manufacturing processes
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 escalate 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 5+ years of related experience with a Bachelor’s degree; or 3 years with a Master’s degree 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.
# LI-Onsite
California residents should review our
Notice for California Employees and Applicants
before applying.
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!Seniority level
Seniority levelMid-Senior level Employment type
Employment typeFull-time Job function
Job functionEngineering and Information Technology IndustriesPharmaceutical Manufacturing Referrals increase your chances of interviewing at Kindeva Drug Delivery by 2x Sign in to set job alerts for “Senior Process Development Engineer” roles. Lexington, KY $107,763.51-$143,684.69 1 week ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr