Ph3Overview /h3pJob Title: Process Engineer /ppLocation: Pisa, Italy /ppAbout Takeda: Present in Italy since 1982, Takeda has two plasma-derived drug production sites in Rieti and Pisa, focusing on therapies derived from immunoglobulins, albumin, and coagulation factors. As partners of the National Health System, Takeda processes plasma into life-saving drugs under the National Self-Sufficiency of Blood and its Products program. Takeda Manufacturing Italia SpA has been awarded the Top Employer certificate for several years and is committed to inclusion, career growth, and sustainability. /ppAbout the Role: The Process Engineer will manage engineering operations for manufacturing in the Pisa plant and provide engineering and maintenance support to sustainably achieve capacity plans and fulfillment targets. They will define maintenance activities for process equipment, provide engineering support, and manage deviations and SOP updates related to process equipment failure. /ph3Responsibilities /h3ulliManage engineering operations for manufacturing operations in the Pisa plant. /liliProvide holistic engineering and maintenance support to sustain capacity plans and fulfillment targets. /liliDefine maintenance activities for process equipment, providing engineering technical support and capital planning and execution. /liliManage deviations, elaborate and update SOPs related to process equipment failure. /li /ulh3Accountabilities /h3ulliEnsure solid performance and efficiency of pharmaceutical equipment, aiming for operational excellence. /liliProvide strategic oversight and act as an advisor or trainer to maintenance and production members. /liliEvaluate potential improvements of process equipment, define implementation strategies, and follow up the change request (CR) process. /liliRespect and ensure that EHS regulations are followed; accountable for EHS activities connected with equipment under responsibilities. /li /ulh3Core Elements Related to this Role /h3ulliDefine maintenance and reinvestment strategies. /liliResponsible for assigned projects. /liliProvide strategic oversight and act as an advisor or trainer to maintenance and production members. /liliPresent issues and results at department and cross-functional meetings; serve as an expert for technical discussions regarding equipment/processes/systems. /liliManage deviations and changes according to GMP rules. /liliPropose and evaluate new ideas or projects with a clear business case and resource assessment. /liliMake alterations and adjustments to processes/equipment; draft/review qualification documents, SOPs, and instructions. /li /ulh3Dimensions and Aspects /h3ulliTechnical/Functional (Line) Expertise: Manage technical records/diagrams; liaise with technical third parties; promote knowledge exchange. /liliLeadership: Provide strategic oversight and training to maintenance and production members. /liliDecision-making and Autonomy: Conduct investigations and RCA; coordinate problem resolution. /liliInteraction: Internal/External functions and resources. /liliInnovation: Promote continuous improvement aligned with internal/external rules. /liliComplexity: Execute projects within challenging timelines and environments. /li /ulh3Education, Behavioral Competencies and Skills /h3ulliMaster's degree in engineering (mechanical, chemical, biomedical, electronic, industrial, automation, etc.). /liliExperience in Visual Inspection, Packaging or similar lines. /liliKnowledge of AutoCAD, PID. /liliIn-depth technical proficiency on pharmaceutical systems and equipment. /liliGood knowledge of cGMPs and pharma/HSE rules and standards. /lili3+ years experience in a pharmaceutical company focused on process, maintenance, technical support, or process/equipment development. /liliFluent in English. /liliStrong multitasking, prioritization and project management skills. /liliLeadership/influence and excellent communication skills (written and verbal). /liliIn-depth knowledge of sterile production processes and equipment. /liliAbility to work effectively within a manufacturing and engineering organization. /li /ulh3What Takeda Can Offer /h3ulliHealth Care Insurance /liliEmployee Stock Purchase Plan /liliEmployee discount programs at various businesses, stores, and medical services /liliTraining on technical skills and professional development /liliJob rotation programs across departments /liliEmployee-led groups focused on Diversity, Equity, and Inclusion and community outreach /liliWellness programs; on-site cafeteria; resources for mental, physical, financial, and spiritual health /liliParental leave /li /ulh3More About Us /h3pTakeda is transforming patient care through novel medicines and patient support programs. Takeda is a Global Top Employer and committed to an inclusive, collaborative workplace dedicated to delivering Better Health and a Brighter Future. /ppLocations: ITA - Pisa /ppWorker Type: Employee /ppWorker Sub-Type: Regular /ppTime Type: Full time /ph3Seniority level /h3ulliMid-Senior level /li /ulh3Employment type /h3ulliFull-time /li /ulh3Job function /h3ulliManagement and Manufacturing /liliIndustries: Pharmaceutical Manufacturing /li /ulpNote: This page includes standard job postings information and is intended for applicants who meet the qualifications described above. /p /p #J-18808-Ljbffr