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.

#J-18808-Ljbffr