Project Manager - Api (Active Pharmaceutical Ingredients)

Bracco is an international Group active in the healthcare sector and a leader in diagnostic imaging. The Group’s main products are contrast agents sold in over 100 countries, both directly and indirectly through branches, joint ventures and license and distribution agreements.

Within the Global Engineering function, the Project Manager - API will be responsible for planning, managing, and supervising complex projects related to facilities for the production of Active Pharmaceutical Ingredients (APIs).
The role requires strong involvement in design, commissioning, and qualification activities, close interaction with internal and external stakeholders, and strict adherence to GMP requirements and international regulatory standards (FDA, EMA, ICH Q7).

Main responsibilities

• Coordinate development, expansion, or revamping projects of API facilities, including pilot plants and production lines.
• Manage design, procurement, commissioning, and qualification phases (FAT, SAT, IQ/OQ) of facilities and automation systems.
• Collaborate with cross-functional teams (engineering, quality, manufacturing, suppliers) to ensure regulatory and technical compliance.
• Monitor project progress in terms of timelines, costs, and quality, ensuring achievement of established milestones.
• Coordinate permitting activities required to obtain authorizations for construction phases.
• Supervise technical and validation documentation through dedicated teams.
• Support the transition to routine production and address potential operational issues.

Requirements

• Degree in Chemical, Mechanical, Management Engineering, or related disciplines.
• Minimum 5 years of experience in pharmaceutical projects, preferably in the API field.
• Solid knowledge of GMP regulations and processes such as chemical synthesis, fermentation, and purification.
• Proficiency in reading P&ID, plant layouts, and technical documentation.
• Strong organizational, communication, and problem-solving skills.
• Good command of English (mandatory) and Italian (preferred).

Preferred qualifications

• Professional certifications (ISPE, GAMP5, or equivalent).
• Familiarity with project management tools (MS Project, Primavera).
• Experience with industrial automation, process control systems, and computer system validation.

If you meet the requirements of this opportunity and would like to join an international group working to improve patients' lives, apply now!

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