Manufacturing Engineer, Yavne Site
Reports to:
Manufacturing Manager
Scinai BioServices supports biopharma innovators from early research to late-phase clinical production, delivering agile, cost-effective, and science-driven CDMO solutions backed by over 20 years of experience and a state-of-the-art cGMP facility.
Our holistic, partnership-focused approach ensures process excellence, accelerated timelines, and value beyond the project, helping innovators bring their therapies to life with confidence.
The company’s Yavne site operates as a CDMO facility specializing in the development, scale-up, technology transfer, and manufacturing of chemistry-based products for pharmaceutical and related industries.
Primary Objectives of the Position
The Manufacturing Engineer will be responsible for supporting the transfer of products and processes from development and prototyping stages into GMP manufacturing. The position plays a key role in bridging R&D and Operations, ensuring robust, efficient, and compliant manufacturing processes. The successful candidate will drive manufacturing readiness activities, prepare production documentation, support process validation, and provide ongoing engineering support to production operations.
Primary Duties and Responsibilities
Lead technology transfer activities from R&D and pilot-scale development into commercial manufacturing.
Support scale-up activities and ensure successful transition of products from prototype to manufacturable processes.
Author, review, and maintain Master Batch Records (MBRs), manufacturing procedures, and related GMP documentation.
Develop and optimize manufacturing processes to improve product quality, efficiency, and reproducibility.
Collaborate closely with R&D, Quality Assurance, Quality Control, Validation, and Operations teams throughout project lifecycles.
Support process qualification, validation, and manufacturing readiness activities.
Provide day-to-day technical support to manufacturing operations and assist in troubleshooting process-related issues.
Participate in investigations related to deviations, non-conformances, OOS results, and CAPA activities.
Ensure all manufacturing activities are performed in compliance with cGMP requirements, internal procedures, and regulatory expectations.
Support implementation of new products, equipment, and manufacturing technologies.
Participate in risk assessments and change control activities.
Analyze manufacturing data and drive continuous improvement initiatives.
Participate in scheduled meetings and routinely report project status and manufacturing activities to the Manufacturing Manager.
Education
B.Sc. in Chemical Engineering, Biotechnology Engineering, Industrial Engineering, Pharmaceutical Engineering, Chemistry, or a related scientific/engineering discipline.
Practical Engineer (Handasai) with relevant industry experience will also be considered.
Experience
2-3 years of experience in pharmaceutical, chemical, medical device, biotechnology, or related regulated manufacturing industries.
Proven experience transferring products from development, pilot, or prototype stages into manufacturing environments.
Experience working within GMP-regulated environments.
Experience writing and managing Master Batch Records (MBRs) and manufacturing documentation.
Experience in a CDMO environment – an advantage.
Experience supporting validation and process qualification activities – an advantage.
Skills
· Strong understanding of process scale-up, technology transfer, and manufacturing optimization, with the ability to translate development activities into robust GMP manufacturing processes.
Knowledge of GMP requirements and documentation practices.
Strong technical writing skills, including SOPs, MBRs, protocols, and reports.
Excellent problem-solving and analytical capabilities.
Strong project management and cross-functional coordination skills.
Ability to manage multiple projects simultaneously in a fast-paced environment.
Strong communication and interpersonal skills.
Team player with the ability to work effectively across departments.
Attention to detail and commitment to quality and compliance.
Languages (speaking, writing, and reading)
Hebrew and English at a high professional level.
Computer Literacy
MS Office is a must.
Experience with ERP systems and electronic document management systems – an advantage
Please submit relevant CVs to Gal.ron@scinai.com