Process Engineering Lead

3 settimane fa

Vicenza, Veneto, Italia Takeda Pharmaceutical A tempo pieno

Job Title: Pharma Process Engineering Lead

Location: Pisa

Job Description:

As a Process Engineering Lead at Takeda Pharmaceutical, you will be responsible for ensuring the solid performance and efficiency of pharmaceutical machinery, aiming for operational excellence. You will lead a department providing oversight to a high-skilled specialist or team of professionals working on diverse topics.

Responsibilities:

  • Supervise the maintenance of equipment in validated conditions, consistently ensuring safety, quality, and compliance with cGMP.
  • Interpret and execute operating policies, procedures, and directives for the department.
  • Define appropriate maintenance and reinvestment strategies.
  • Responsible for all projects assigned to the organizational unit.
  • Promote continuous improvement of processes and equipment, ensuring alignment with the latest internal and external rules and regulations.
  • Act as an industry expert for the site within the global network.
  • Ensure 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.
  • Provide strategic oversight and act as an advisor or trainer to subordinate managers or staff members.
  • Formulate, prioritize, and execute a multiple technical project agenda.
  • Frequently present challenging issues and results at the department and cross-functional gatherings as well as project team meetings.
  • Serve as an expert and the focal point for technical discussions regarding equipment, processes, and systems.
  • Manage deviations and changes according to GMP rules.
  • Act as the point of contact in the event of regulatory or EHS inspections.
  • Propose and evaluate new ideas or projects, formulating precise business cases and assessing costs and resources.
  • Conduct investigations and coordinate the resolution of problems and root cause analysis (RCA).
  • Make alterations and adjustments to processes and equipment.
  • Draft and review qualification documents, evaluations, technical Standard Operating Procedures (SOPs), and instructions.
  • Manage technical records and diagrams.
  • Promote and lead the exchange of technical knowledge within and outside the site.
  • Manage relationships with technical third parties, such as equipment suppliers, directly handling service requests and agreements.

Requirements:

  • Master's 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 of experience in a pharmaceutical company with a 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
  • Excellent communication skills: written and verbal
  • Prioritization and project management skills
  • High-level problem-solving/root cause investigation skills
  • Creative capacity for developing new ways to do things better, cheaper, faster

About Us:

Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work. Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering Our People to Shine:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.

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