Senior Process Development Engineer II
About The Position
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.
Requirements
- 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
Nice To Haves
- 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
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)
- Translate lab-scale processes into commercial manufacturing processes
- 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
- 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)
- Serve as technical liaison between engineering, R&D, manufacturing, QA, and regulatory
- Coordinate with customers, vendors, and external partners
- 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
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
1,001-5,000 employees
