Overview
Job Title: Process Engineer
Location: Pisa, Italy
About 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.
About 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.
Responsibilities
* Manage engineering operations for manufacturing operations in the Pisa plant.
* Provide holistic engineering and maintenance support to sustain capacity plans and fulfillment targets.
* Define maintenance activities for process equipment, providing engineering technical support and capital planning and execution.
* Manage deviations, elaborate and update SOPs related to process equipment failure.
Accountabilities
* Ensure solid performance and efficiency of pharmaceutical equipment, aiming for operational excellence.
* Provide strategic oversight and act as an advisor or trainer to maintenance and production members.
* Evaluate potential improvements of process equipment, define implementation strategies, and follow up the change request (CR) process.
* Respect and ensure that EHS regulations are followed; accountable for EHS activities connected with equipment under responsibilities.
Core Elements Related to this Role
* Define maintenance and reinvestment strategies.
* Responsible for assigned projects.
* Provide strategic oversight and act as an advisor or trainer to maintenance and production members.
* Present issues and results at department and cross-functional meetings; serve as an expert for technical discussions regarding equipment/processes/systems.
* Manage deviations and changes according to GMP rules.
* Propose and evaluate new ideas or projects with a clear business case and resource assessment.
* Make alterations and adjustments to processes/equipment; draft/review qualification documents, SOPs, and instructions.
Dimensions and Aspects
* Technical/Functional (Line) Expertise: Manage technical records/diagrams; liaise with technical third parties; promote knowledge exchange.
* Leadership: Provide strategic oversight and training to maintenance and production members.
* Decision-making and Autonomy: Conduct investigations and RCA; coordinate problem resolution.
* Interaction: Internal/External functions and resources.
* Innovation: Promote continuous improvement aligned with internal/external rules.
* Complexity: Execute projects within challenging timelines and environments.
Education, Behavioral Competencies and Skills
* Master's degree in engineering (mechanical, chemical, biomedical, electronic, industrial, automation, etc.).
* Experience in Visual Inspection, Packaging or similar lines.
* Knowledge of AutoCAD, P&ID.
* In-depth technical proficiency on pharmaceutical systems and equipment.
* Good knowledge of cGMPs and pharma/HSE rules and standards.
* 3+ years experience in a pharmaceutical company focused on process, maintenance, technical support, or process/equipment development.
* Fluent in English.
* Strong multitasking, prioritization and project management skills.
* Leadership/influence and excellent communication skills (written and verbal).
* In-depth knowledge of sterile production processes and equipment.
* Ability to work effectively within a manufacturing and engineering organization.
What Takeda Can Offer
* Health Care Insurance
* Employee Stock Purchase Plan
* Employee discount programs at various businesses, stores, and medical services
* Training on technical skills and professional development
* Job rotation programs across departments
* Employee-led groups focused on Diversity, Equity, and Inclusion and community outreach
* Wellness programs; on-site cafeteria; resources for mental, physical, financial, and spiritual health
* Parental leave
More About Us
Takeda 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.
Locations: ITA - Pisa
Worker Type: Employee
Worker Sub-Type: Regular
Time Type: Full time
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Management and Manufacturing
* Industries: Pharmaceutical Manufacturing
Note: This page includes standard job postings information and is intended for applicants who meet the qualifications described above.
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