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Lead Engineer for Pharma Process Optimization

2 mesi fa

Pisa, Toscana, Italia Takeda A tempo pieno

Position Overview

We are seeking a highly skilled professional to take on the role of Pharma Process Engineering Lead. This position is essential for ensuring the optimal performance and efficiency of pharmaceutical machinery, with a strong focus on operational excellence.

Key Responsibilities

  • Oversee the performance and efficiency of pharmaceutical machinery, driving operational excellence.
  • Lead a team of specialized professionals, providing guidance and oversight on various projects.
  • Ensure that all equipment is maintained in validated conditions, prioritizing safety, quality, and compliance with current Good Manufacturing Practices (cGMP).
  • Implement and interpret departmental policies, procedures, and directives.
  • Develop and define maintenance and reinvestment strategies for equipment.
  • Manage all projects assigned to the unit, ensuring timely and effective execution.
  • Foster continuous improvement in processes and equipment, aligning with the latest industry regulations.
  • Serve as a subject matter expert within the global network, providing technical expertise.
  • Ensure the technical proficiency of process engineers and technicians through high standards and effective methodologies.
  • Provide strategic oversight and act as a mentor to subordinate managers and staff.
  • Formulate and prioritize a diverse technical project agenda.
  • Present complex issues and outcomes at departmental and cross-functional meetings.
  • Act as the primary contact for technical discussions related to equipment, processes, and systems.
  • Manage deviations and changes in accordance with GMP regulations.
  • Serve as the point of contact during regulatory or Environmental Health and Safety (EHS) inspections.
  • Propose and assess new ideas or projects, creating detailed business cases and evaluating resources.
  • Conduct investigations and coordinate problem resolution and root cause analysis.
  • Make necessary adjustments to processes and equipment as required.
  • Draft and review qualification documents, technical Standard Operating Procedures (SOPs), and instructions.
  • Maintain technical records and diagrams.
  • Promote and facilitate the exchange of technical knowledge within and outside the organization.
  • Manage relationships with technical third parties, including equipment suppliers, and handle service requests.

Qualifications

  • Master’s degree in engineering (mechanical, electronic, industrial, automation, etc.).
  • Extensive technical knowledge of pharmaceutical systems and equipment.
  • Strong understanding of cGMPs and pharmaceutical/HSE regulations.
  • Over 10 years of experience in the pharmaceutical industry, focusing on process, maintenance, and technical support.
  • Proficiency in English is required.

Preferred Skills

  • Exceptional ability to manage multiple tasks and competing priorities.
  • Strong leadership and influence capabilities.
  • In-depth knowledge of sterile production processes and associated equipment.
  • Excellent communication skills, both written and verbal, with the ability to work effectively within a team.
  • Strong project management and prioritization skills.
  • High-level problem-solving and root cause investigation abilities.
  • Creative thinking for developing innovative solutions.

About Takeda

At Takeda, we are dedicated to transforming patient care through the development of innovative specialty pharmaceuticals and exceptional patient support programs. We are a patient-focused organization that encourages growth through impactful work.

As a certified Global Top Employer, Takeda offers rewarding career opportunities, fosters innovation, and strives for excellence in all endeavors. We are committed to creating an inclusive and collaborative workplace, where our teams are united in delivering Better Health and a Brighter Future globally.

Commitment to Diversity

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