Process Engineer (PEA_06.2023) (PEA)
FAMAR is a European contract manufacturing and development partner, for the pharmaceutical and health & beauty industry. Building on our 70 years’ expertise, we deliver flexible solutions, from development to production and distribution. Driven by our customer-care mindset, we offer services covering the majority of pharmaceutical forms, while providing a particularly strong expertise in Liquids, Ointments and Creams. Through the outstanding knowledge and commitment of our employees and with a network of 6 production sites, 3 R&D sites and one distribution centre, we supply a wide range of more than products in international markets.We are currently seeking to recruit for Alimos BU:Process Engineer (PEA_ 08.)DUTIES AND RESPONSIBILITIES: Reports to Head of Production & PackagingResponsible for transferring new products to FAMAR Alimos production lines. Collaborates with Project Managers, QA, QC departments and customers technical team to asses and complete the transfer process successfullyAssessment of RFQs for new products regarding process feasibility, batch size, investment needs and routings in collaboration with the Production and Packaging ManagerResponsible to transfer current products in alternative equipmentResponsible for organizing and facilitating project-based endeavors, which may include identifying and resolving operational issues, enhancing productivity, reducing waste, improving customer service, or reducing costs.Analysis of shoopfloor’’s processes by making suggestions on how to improve them, working with other departments in recognizing opportunities, making and implementing changes, and sustaining improvements. Recognizing opportunities, making and implementing changes, and sustaining improvementsSupervises trials, engineering and validation batches. Ensures appropriate execution of the production and sampling process together with IPC, QC, QA personnelResponsible to review/approve trial, validation protocols and reports issued by QA departmentResponsible to prepare, review and update Manufacturing Instructions for all productsResponsible to prepare, review and update working instruction and templates of the Production departmentResponsible to train relevant production personnel in new or updated manufacturing instructions, standard operating procedures and working instructionsCollaborates with the Production, QA department and customers to improve current products and production processes. Supervises manufacturing processes to identify gaps and improvement opportunitiesParticipates in improvement or product remediation projects with customers, suppliers, QA, R&D departmentsParticipates in risk assessment with QA department when changing a raw material supplier or specificationPerforms gap analyses and risk assessment when a new product is transferred or for changes in current products, processes or equipmentResponsible to prepare change control for equipment or process changes in the production departmentParticipates and organize training activities when a new equipment is installed in AlimosResponsible to implement corrective and preventive actions (CAPA) for Production departmentResponsible to investigate recurrent deviations and improve processes/equipment efficiency, yield, GMP compliance ProfilE / SKILLS:Academic Background: University Degree in Chemistry/Chemical Engineering/Pharmacy Languages: Fluent in English (advanced oral and written skills). Special Knowledge PC literacy (MS Office, Word, Excel, PowerPoint)SAP system knowledge will be an assetLean 6 Sigma Certification will be an asset Qualifications 3-5 years’ experience in the pharmaceutical industry in relevant position (Sterile products forms preferred) Ability to work under pressure and with cross-functional teamsProblem solvingProject managementChange managementOperational Excellence