Senior Process Development Engineer II

2 weeks ago

Lexington, KY, United States Kindeva Drug Delivery Full time
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:

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
  • 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.

# LI-Onsite

California residents should review our Notice for California Employees and Applicants before applying.

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

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