Senior Process Development Engineer II
Our Work MattersAt Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.The Impact You Will MakeJoin 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.ResponsibilitiesTechnology TransferPlan and execute technology transfer activities for drug products or devices from R&D to manufacturing or between commercial sitesAuthor and/or review tech transfer documentation (e.g., process descriptions, gap assessments, risk assessments, readiness assessments, protocols)Translate lab-scale processes into commercial manufacturing processesProcess Optimization & TroubleshootingSupport scale-up activities and resolve technical issues during manufacturingWork with R&D to adapt and optimize processes for commercial equipmentImplement process improvements to enhance product quality, yield, and efficiencyDocumentation & ComplianceEnsure all tech transfer activities are documented per regulatory requirementsSupport regulatory submissions and inspections/auditsDraft production documentation including batch records and protocolsSupport validation and qualification efforts (process, equipment, cleaning)Cross-Functional CollaborationServe as technical liaison between engineering, R&D, manufacturing, QA, and regulatoryCoordinate with customers, vendors, and external partnersTraining & SupportTrain manufacturing staff on transferred processesFacilitate knowledge transfer and review development historyTroubleshoot and escalate risks with proposed mitigation strategiesEnsure effective and compliant transfer of knowledge, data, and technologyProblem SolvingApply scientific and statistical methods to analyze and diagram production processesLead structured problem-solving to identify root causes and develop solutionsDrive Risk Management tools like Fault Tree Analysis and FMEAAddress diverse technical problems requiring informed judgment and adaptive techniquesProvide technical leadership and guidance to others as a subject matter expertQualificationsMinimum Qualifications RequiredBS in engineering/related degree or equivalent experience8+ 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 transfersWorking knowledge of cGMP, GAMP5, and regulatory requirementsPreferred QualificationsExperience working with nasal spray products/devices or related drug-delivery technologiesStrong technical and nontechnical communication skillsExperience supporting client/regulatory audits and follow-up responsesExtensive technical writing experienceJoin our One Team mission of manufacturing more tomorrows. Your expertise will help ensure better health and well-being for patients worldwide.# LI-OnsiteCalifornia 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 EmployerKindeva 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!