Commissioning & Qualification Engineer

Trovato in: beBee jobs IT - 3 settimane fa

Colleretto Giacosa, Italia AAA Italy Srl. A tempo pieno

The Commissioning & Qualification Engineer provides the Site with Subject Matter Expert (SME) knowledge and skills related to commissioning and qualification activities and requirements of Plants and Equipment as well as management of related Changes and Deviations.

The C&Q Engineer oversees processes and standards to maintain and improve existing manufacturing technologies and to aid in the implementation of innovative improvements.

Manages and collaborates with external consultants and internal resources to achieve timely document generation and execution according to regulatory and project requirements.


Your key responsibilities:
Your responsibilities include, but are not limited to:

  • Being responsible for the generation and maintenance of the Commissioning and Qualification relevant procedures and documents (Risk Assessment/Periodic Requalification Planning/System Impact Assessment).
  • Write, review or approve C&Q protocols and reports under its area of responsibility (HVAC, Utilities, Production Equipment, Lab Equipment).
  • Manage and support external/internal validation technicians during planning and execution of C&Q activities.
  • Work with the local Engineering team and Site Leadership Team to define priorities on the C&Q of new equipment as well as process/compliance improvements on existing processes and equipment.
  • Being responsible for the management of Change Controls and Deviations related to Plants and Equipment.
  • Support Maintenance and Calibration Functions to improve compliance and quality
  • Supports the Aseptic Expert(s) / Process Experts in troubleshooting / root cause investigation by providing a second level of specialist expertise as SME and by harmonizing and optimizing related technical processes across the units
  • Interfaces with local and global Engineering networks and with the technical development organization, for the corresponding global activities, to define and implement new technical standards for existing and new technologies and equipment.
  • Collaborate with technical development, other sites, and the global engineering network to facilitate the transfer of technical knowledge.