In sintesi
- Mansioni: Sviluppa documentazione per Commissioning, Qualificazione e Validazione in ambito farmaceutico.
- Azienda: Azienda innovativa nel settore Life Sciences con un ambiente collaborativo.
- Benefit: Salario competitivo, opportunità di crescita professionale e lavoro flessibile.
- Altre informazioni: Ambiente dinamico con possibilità di viaggiare in Italia e all'estero.
- Perché questo lavoro: Fai la differenza nel settore farmaceutico e lavora su progetti all'avanguardia.
- Qualifiche: Esperienza in ingegneria o scienze, con attenzione ai dettagli e capacità di problem-solving.
La retribuzione prevista è compresa tra 34000 - 45000 € per anno.
Position
Description: We are now seeking a CQV Engineer to join our growing operations in Italy.
The CQV Engineer develops the documentation to support Commissioning, Qualifications, and Validation.
These people are responsible for protocol writing and execution, field verification, and development of summary reports at the client site.
The role of a CQV Engineer in CAI is to: Support documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment.
Responsible for protocol writing and execution (field verification), and development of summary reports at client sites.
Position
Requirements: High attention to detail Ability to multi-task and take initiative to accomplish assigned tasks accurately by established BS or MS in a relevant science or engineering field, or equivalent years of hands-on experience Minimum 4 - 8 years’ experience performing commissioning and / or qualification activities in an FDA regulated industry.
Ideally, you will already have experience in facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC), building automation or other pharmaceutical manufacturing processes and equipment, FAT/SAT, URS, design review, P&IDs, IQ/OQ/PQs, generation & execution, etc.
Provide c GMP leadership and guidance for the integration and delivery of CQV services for our Life Sciences clients.
Excellent technical problem-solving and troubleshooting skills, with solid knowledge of typical project technical issues deadlines Ability to work independently, while quickly building and nurturing a project team Managing the C&Q documentation and execution lifecycle from SLIA generation through to OQ completion.
Support onsite and offsite activities, such as: FATs, SATs, IOQ and PQ Executions and System Walkdowns Proficient in life science manufacturing processes in areas such as biotech, aseptic processing, aseptic fill/finish, OSD, Gene Therapy or equivalent experience.
Familiarity with Baseline Guide 5 (Second Edition) a plus Expected skills: Isolators qualification protocols execution and reporting, VHP cycle development, GMP based knowledge Expertise in Microsoft Word and Excel Excellent oral and written English are required.
Available for travel in Italy and abroad.
The compensation package offered ranges from €34,000 to €45,000 gross per annum (Gross Annual Salary).
The final salary within this range will be determined according to the candidate’s technical competencies and relevant professional experience.
La selezione rispetta il principio delle pari opportunità (l. 903⁄77) We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information.
These tools assist our recruitment team but do not replace human judgment.
Final hiring decisions are ultimately made by humans.
If you would like more information about how your data is processed, please contact us.
The compensation package offered ranges from €34,000 to €45,000 gross per annum (Gross Annual Salary).
The final salary within this range will be determined according to the candidate’s technical competencies and relevant professional experience.
CQV Engineer Staff I datore di lavoro: CAI
Lavorare come CQV Engineer presso la nostra azienda in Italia significa unirsi a un ambiente stimolante e collaborativo, dove l'attenzione ai dettagli e l'innovazione sono al centro di tutto. Offriamo opportunità di crescita professionale attraverso progetti significativi nel settore delle scienze della vita, supportati da un pacchetto retributivo competitivo e un forte impegno per la formazione continua. La nostra cultura aziendale promuove la diversità e l'inclusione, garantendo che ogni dipendente possa contribuire e prosperare nel proprio ruolo.
