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Job Description

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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 topic.
• 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 oversights and acts as an advisor or trainer to subordinate manager or staff members.
• Formulates, prioritizes, and executes a multiple technical project agenda.
• Frequently presents challenging issues and results at the 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.

Requirments

• 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 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

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. 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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