PpJoin to apply for the bCommissioning Manager /b role at bJefferson Wells Italia /b /p pWe 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. /p pThe 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. /p pThe 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. /p h3Key Responsibilities /h3 ul liDevelop and maintain the Commissioning Plan and related schedules. /li liLead and coordinate all commissioning shopfloor activities across mechanical, electrical, instrumentation, utilities, and automation systems. /li liPrepare and manage technical documentation, including FAT, SAT, commissioning protocols, punch lists, and final reports. /li liParticipate in system walk-downs and manage non-conformities until resolution. /li liOversee performance testing, cleaning validation, and qualification of critical systems (e.g., HVAC, purified water, process utilities). /li liEnsure all commissioning milestones are achieved in line with project timelines and regulatory requirements. /li liManage variations arising during commissioning, including documentation updates and design modifications. /li liCollaborate with internal stakeholders (Engineering, Production, Quality, HSE, Maintenance) and external contractors/vendors to ensure alignment and compliance. /li liIssue system handover certificates and ensure readiness for qualification and validation phases. /li /ul h3Required Qualifications /h3 ul liBachelor’s or Master’s degree in Chemical, Mechanical, or Pharmaceutical Engineering, or related technical discipline. /li li5–7 years of field experience in commissioning within fine chemical, FMCG/pharmaceutical or API manufacturing projects. /li liStrong knowledge of GMP, regulatory standards (FDA, EMA, ICH Q7), and safety regulations. /li liProven ability to lead multidisciplinary teams and manage interfaces across multiple functions. /li liProficiency in interpreting PIDs, technical drawings, and facility layouts. /li liStrong organizational, documentation, and problem-solving skills. /li /ul h3Preferred Skills /h3 ul liFamiliarity with validation protocols (IQ/OQ/PQ) and technical standards (ISPE, GAMP5). /li liExperience with SCADA, DCS, and automation platforms. /li liKnowledge of project management tools (e.g., MS Project, Primavera). /li liPrevious exposure to API processes (chemical synthesis, fermentation, purification). /li liLean Manufacturing/TPM/Early Management knowledge. /li /ul h3Key Interfaces /h3 ul liGlobal Engineering and Site Engineering teams. /li liProduction and Maintenance departments. /li liHSE and Quality Assurance functions. /li liContractors, vendors, and third-party service providers. /li liApproved Commissioning Plan and schedule. /li liSystem matrices and applicable procedures. /li liCommissioning reports, punch lists, and system handover certificates. /li liDocumentation of variations and progress status. /li /ul h3Seniority Level /h3 pMid-Senior level /p h3Employment Type /h3 pFull-time /p h3Job Function /h3 pProduction and Engineering /p h3Industries /h3 pPharmaceutical Manufacturing and Chemical Manufacturing /p /p #J-18808-Ljbffr