Commissioning Manager

Join to apply for the Commissioning Manager role at Jefferson Wells Italia We are looking for a Commissioning Manager on behalf of Bracco Imaging, life sciences company specialized in the development, production, and commercialization of contrast agents and advanced solutions for diagnostic imaging. The Commissioning Manager is responsible for ensuring the successful start-up and handover of systems within capital projects in the pharmaceutical API sector. The role guarantees compliance with GMP standards, international regulatory requirements (FDA, EMA, ICH Q7), as well as safety, quality, and environmental standards. This position plays a critical part in ensuring a smooth transition from project completion to validation and routine production. The Commissioning Manager acts as owner representative and interacts with the EPCM Commissioning Manager and OEM Commissioning Teams. He/She will be the FPOC between the internal (Bracco Global Engineering and Bracco Plant Teams) and the external (EPCM/OEMs) organization. He/She will be responsible for building the Bracco commissioning standards and protocols within the Company’s Project Management process and documentation. Key Responsibilities Develop and maintain the Commissioning Plan and related schedules. Lead and coordinate all commissioning shopfloor activities across mechanical, electrical, instrumentation, utilities, and automation systems. Prepare and manage technical documentation, including FAT, SAT, commissioning protocols, punch lists, and final reports. Participate in system walk-downs and manage non-conformities until resolution. Oversee performance testing, cleaning validation, and qualification of critical systems (e.g., HVAC, purified water, process utilities). Ensure all commissioning milestones are achieved in line with project timelines and regulatory requirements. Manage variations arising during commissioning, including documentation updates and design modifications. Collaborate with internal stakeholders (Engineering, Production, Quality, HSE, Maintenance) and external contractors/vendors to ensure alignment and compliance. Issue system handover certificates and ensure readiness for qualification and validation phases. Required Qualifications Bachelor’s or Master’s degree in Chemical, Mechanical, or Pharmaceutical Engineering, or related technical discipline. 5–7 years of field experience in commissioning within fine chemical, FMCG/pharmaceutical or API manufacturing projects. Strong knowledge of GMP, regulatory standards (FDA, EMA, ICH Q7), and safety regulations. Proven ability to lead multidisciplinary teams and manage interfaces across multiple functions. Proficiency in interpreting P&IDs, technical drawings, and facility layouts. Strong organizational, documentation, and problem-solving skills. Preferred Skills Familiarity with validation protocols (IQ/OQ/PQ) and technical standards (ISPE, GAMP5). Experience with SCADA, DCS, and automation platforms. Knowledge of project management tools (e.g., MS Project, Primavera). Previous exposure to API processes (chemical synthesis, fermentation, purification). Lean Manufacturing/TPM/Early Management knowledge. Key Interfaces Global Engineering and Site Engineering teams. Production and Maintenance departments. HSE and Quality Assurance functions. Contractors, vendors, and third-party service providers. Approved Commissioning Plan and schedule. System matrices and applicable procedures. Commissioning reports, punch lists, and system handover certificates. Documentation of variations and progress status. Seniority Level Mid-Senior level Employment Type Full-time Job Function Production and Engineering Industries Pharmaceutical Manufacturing and Chemical Manufacturing #J-18808-Ljbffr