Process Engineering Lead
1 mese fa
By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Title: Pharma Process Engineering Lead
Location: Pisa
Job Description Responsibilities Ensures solid performance and efficiency of pharmaceutical machinery, aiming for operational excellence. Leader of a department providing oversight to a high skilled specialist or team of professionals working on diverse topics. Supervises the maintenance of equipment in validated conditions, consistently ensuring safety, quality, and compliance with cGMP. Interprets and executes operating policies, procedures and directives for the department. Defines appropriate maintenance and reinvestment strategies. Responsible for all projects assigned to the organizational unit. Promotes continuous improvement of processes and equipment, ensuring alignment with the latest internal and external rules and regulations. Acts as an industry expert for the site within the global network. Ensures the technical competence of process engineers and technicians through the adoption of high standards, efficient methodologies, a data-centric approach, and a dedication to fundamental engineering principles. Provides strategic oversight and acts as an advisor or trainer to subordinate managers or staff members. Formulates, prioritizes, and executes a multiple technical project agenda. Frequently presents challenging issues and results at department and cross-functional gatherings as well as project team meetings. Serves as an expert and the focal point for technical discussions regarding equipment/processes/systems. Manages deviations and changes according to GMP rules. Acts as the point of contact in the event of regulatory or EHS inspections. Proposes and evaluates new ideas or projects, formulating precise business cases and assessing costs and resources. Conducts investigations and coordinates the resolution of problems and root cause analysis (RCA). Makes alterations and adjustments to processes/equipment. Drafts/reviews qualification documents, evaluations, technical Standard Operating Procedures (SOPs), and instructions. Manages technical records and diagrams. Promotes and leads the exchange of technical knowledge within and outside the site. Manages relationships with technical third parties such as equipment suppliers, directly handling service requests and agreements. Requirements: Master degree in engineering (mechanical, electronic, industrial, automation, etc…) In-depth technical proficiency on pharmaceutical systems and equipment. Good knowledge of cGMPs and pharma/HSE rules and standards. 10+ years experience in a pharmaceutical Company with specific focus on process, maintenance, technical support, process/equipment development. Fluent in English. Additional Skills/Preferences Exceptional ability to manage simultaneous activities, competing priorities, and challenges. Leadership / influence. In-depth knowledge of the sterile production process and equipment. Strong ability to work and communicate effectively with the team and peers within a manufacturing and engineering organization. This includes excellent communication skills: written and verbal. Prioritization & project management skills. High-level problem-solving / root cause investigation skills. Creative capacity for developing new ways to do things better, cheaper, faster.
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