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CQV Engineer Bologna

2 mesi fa

Bologna, Emilia-Romagna, Italia CAI A tempo pieno
Job Description

Position Overview:

We are seeking a highly skilled CQV Engineer to join our team at CAI in Italy. The successful candidate will be responsible for developing documentation to support Commissioning, Qualifications, and Validation of pharmaceutical facilities, utilities, and equipment.

Key Responsibilities:

  1. Develop and maintain comprehensive documentation for Commissioning, Qualification, and Validation activities.
  2. Write and execute protocols for field verification and develop summary reports at client sites.
  3. Provide technical leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients.
  4. Collaborate with cross-functional teams to ensure seamless project execution and delivery.
  5. Manage the C&Q documentation and execution lifecycle from SLIA generation through to OQ completion.
  6. Support onsite and offsite activities, such as FATs, SATs, IOQ and PQ Executions, and System Walkdowns.
  7. Stay up-to-date with industry regulations and guidelines, including cGMP and Baseline Guide 5 (Second Edition).

Requirements:

  1. BS or MS in a relevant science or engineering field, or equivalent years of hands-on experience.
  2. Minimum 4 – 8 years' experience performing commissioning and/or qualification activities in an FDA regulated industry.
  3. Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues.
  4. High attention to detail and ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines.
  5. Ability to work independently and as part of a project team.
  6. Proficient in life science manufacturing processes in areas such as biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy or equivalent experience.
  7. Excellent oral and written English language skills.
  8. Available for travel in Italy and abroad.

Preferred Qualifications:

  1. Expertise in Microsoft Word and Excel.
  2. Familiarity with Baseline Guide 5 (Second Edition).

Equal Opportunities Employer:

CAI is an equal opportunities employer and welcomes applications from all qualified candidates.